Cepheid Xprstrepa-ce-10 Henry Schein Medical Instruction Manual

XPRSTREPA-CE-10 Henry Schein Medical

Product Information

• Product Name: Cepheid Pipette
• Part Number: XPRSTREPA-CE-10
• Manufacturer: Sunnyvale
• Manufacturer Registration Number: US-MF-000010979

Product Usage Instructions

1. When executing a test, follow all instructions as normal per
   the Package Insert.
2. To transfer patient sample to a cartridge using the pipette,
   refer to the Package Insert for detailed instructions and
   visualization of the proper squeezing technique.
3. If the pipette fails to aspirate an adequate volume of liquid,
   follow these steps:
   1. Ensure that you have followed the guidelines for proper use of
      the pipette.
   2. If the issue persists, repeat the steps using a new
      pipette.

Please note that the pipette quality issue is intermittent, and
Cepheid is working with their supplier to correct it. It is
important to share this information with your laboratory staff and
retain this notification as part of your laboratory Quality System
documentation. If you have forwarded any affected products to
another laboratory, please provide them with a copy of this
letter.

If you have any questions regarding this notice, refer to the
contact information provided below:

April 24, 2023
IMPORTANT PRODUCT NOTICE
Xpert® Xpress Strep A
Attention Cepheid Customer,
We are writing to inform you that Cepheid has initiated a field action for the product listed in the attachment. Specifically, Cepheid has become aware and has determined that pipettes packaged in our XPRSTREPA-10 or XPRSTREPA-CE-10 products may fail to dispense an adequate sample volume. In our internal testing, some pipettes have failed at a higher-than-expected rate, to aspirate the expected volume of ESwab transport medium containing the patient sample and have instead delivered a lower volume. We believe this lower volume of ESwab transport medium containing the patient sample has resulted in increased complaints from certain users mainly resulting in `Invalid’ or `No Result’ test results. Discrepant Results (False Negatives), though unlikely, can occur and we recommend continuing to follow the instructions in our Package Insert as stated below:
Per the Package Insert, a negative test result does not exclude the possibility of the presence of Streptococcus pyogenes because the test result may be affected by improper specimen collection, technical error, sample mix-up, or because the number of organisms in the sample is below the limit of detection of the test. As with many diagnostic tests, negative results from the Xpert Xpress Strep A test do not preclude a Strep A infection and should not be used as the sole basis for treatment or other patient management decisions. The results from the Xpert Xpress Strep A test should be interpreted in conjunction with other laboratory and clinical data available to the clinician.
Please note that we are working with our pipette supplier to correct this issue.
Because the pipette quality issue is intermittent, Cepheid is asking that you do the following:
When executing a test, please follow all instructions as normal per the Package Insert. Regarding using the pipette for transferring patient sample to a cartridge, please refer to the Package Insert detailing and providing a visualization of the proper squeezing of the pipette.

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If, upon following this guideline for proper use of the pipette you determine that your pipette fails to aspirate an adequate volume of liquid, repeat the steps using a new pipette.

We ask that you acknowledge receipt of this Important Product Notice by responding via a web request from https://www.cepheid.com/streppipette (for US customer only) or by completing the enclosed Customer Response Form (email or Fax). In addition, replacement pipettes, if needed, can be requested via the above mentioned process. Please complete this activity within 10 days, so we are assured you have received this important communication. The Customer Response Form can be emailed to [email protected] or faxed to +1 (408) 716-3143. Your response will be received at the email address above and Cepheid does not send reply or confirmation emails related to your response.

Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter.

If you have any questions regarding this notice, please refer to the table for applicable contact information.

We apologize for the inconvenience that this caused your laboratory. Sincerely,

Somesh Lalithraj
Somesh Lalithraj (Apr 24, 2023 22:12 PDT)

Apr 24, 2023

Somesh Lalithraj Vice President, Global Quality

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Region US Australia and New Zealand
Brazil and Latin America
Canada
China
France
Germany
Japan Middle East Portugal Spain Other European, Middles East, and African countries Other Countries not listed

Telephone + 1 888 838 3222, option 2 + 61 1800 130 821 + 64 0800 001 028
+ 0080 941 4610

Technical Support Email [email protected]
[email protected] [email protected]

+1 855-202-6160

[email protected]

+ 86 021 5406 5387

[email protected]

+ 33 563 825 319

[email protected]

+ 492151-3280-100

[email protected]

+ 0120 95 4886

[email protected]

+ 27 861 22 76 35
+ 800 913 174
+ 34 919 90 6762 + 33 563 825 319 + 971 4 253 3218 + 1 408 400 8495

[email protected] [email protected] [email protected] [email protected]
[email protected]

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Customer Name:
Ship to Address:
Phone Number:
E-mail:

Please return only completed Customer Response Form to Cepheid by email
[email protected] or FAX (408) 716-3143
CUSTOMER RESPONSE FORM
Xpert® Xpress Strep A (please see the product list at the end)

Please select one choice: I acknowledge receipt of this letter and I am not requesting any replacement product.
Or:
I acknowledge receipt of this letter, certify that I have Xpert® Xpress Strep A. I am requesting replacement pipettes.

Quantity On-hand: ______ bags of pipettes (bag of 12 pipettes) Product Disposal Attestation: I attest that I will dispose of any remaining pipettes.

Print Name:

Print Title:

Signature:

Date:

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Xpert® Xpress Strep A

Legal Manufacturer is Sunnyvale with Single Registration Number (SRN) US-MF-000010979.

Unique Device Identifier (UDI) 07332940006297 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372

Part Number XPRSTREPA-CE-10
XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10

Batch Number 1000613359 1000413767 1000470375 1000478705 1000482576 1000489420 1000492158 1000494468 1000494469 1000494470 1000494471 1000495394 1000495396 1000496223 1000496224 1000501407 1000501663 1000502282 1000502290 1000506351 1000507305 1000508428 1000510024 1000514762 1000514765 1000514772 1000516576 1000518826 1000519450 1000520779 1000520869 1000522864 1000522877 1000527214 1000527215 1000527216 1000535892 1000535895 1000535906

Lot Number 23815 10309 23201 23305 23308 23312 23314 23315 23401 23402 23403 23404 23405 23406 23407 23501 23504 23505 23506 23408 23410 23510 23411 23604 23605 23607 23608 23609 23610 23611 23612 23701 23702 23703 23705 23706 23707 23708 23709

Expiration Date 26-Nov-23 21-May-23 23-Jul-23 30-Jul-23 06-Aug-23 13-Aug-23 20-Aug-23 20-Aug-23 20-Aug-23 20-Aug-23 20-Aug-23 20-Aug-23 20-Aug-23 20-Aug-23 20-Aug-23 27-Aug-23 27-Aug-23 27-Aug-23 27-Aug-23 03-Sep-23 03-Sep-23 03-Sep-23 10-Sep-23 17-Sep-23 17-Sep-23 17-Sep-23 17-Sep-23 17-Sep-23 17-Sep-23 17-Sep-23 17-Sep-23 24-Sep-23 24-Sep-23 24-Sep-23 24-Sep-23 24-Sep-23 08-Oct-23 08-Oct-23 08-Oct-23

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Unique Device Identifier (UDI) 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372 07332940006372

Part Number XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10 XPRSTREPA-10

Batch Number 1000535907 1000535908 1000542612 1000543679 1000544555 1000544577 1000552140 1000552141 1000552142 1000560158 1000566813 1000605218 1000693093 1000753684 1000757279 1000763861 1000778789 1000784990 1000785035 1000785324 1000799629 1000801610 1000801727 1000808180 1000808181 1000808182 1000808183 1000810140 1000810141 1000810317 1000810318 1000823007

Lot Number 23710 23711 23712 23714 23716 23717 23718 23719 23720 23113 23316 23912 24112 23820 24704 24302 24307 24507 24508 24511 23822 23823 23824 24512 24513 24514 23825 24313 24515 24516 24517 24805

Expiration Date 08-Oct-23 08-Oct-23 08-Oct-23 08-Oct-23 15-Oct-23 15-Oct-23 22-Oct-23 22-Oct-23 22-Oct-23 29-Oct-23 29-Oct-23 26-Nov-23 14-Jan-24 11-Feb-24 18-Feb-24 18-Feb-24 25-Feb-24 03-Mar-24 03-Mar-24 03-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 10-Mar-24 17-Mar-24

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References

• Adobe Acrobat Sign
• Cepheid Strep A Product Notice (April 2023)