Cepheid XPRSTREPA-CE-10 Henry Schein Medical Instruction Manual
- June 12, 2024
- Cepheid
Table of Contents
April 24, 2023
IMPORTANT PRODUCT NOTICE
Xpert® Xpress Strep A
XPRSTREPA-CE-10 Henry Schein Medical
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’ orNo 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.
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
| Region | Telephone | Technical Support Email |
|---|---|---|
| US | +1 888 838 3222, option 2 |
[email protected]
Australia and New Zealand| +61 1800 130 821|
[email protected]
Brazil and Latin America| +64 0800 001 028|
[email protected]
Canada| +1 855-202-6160|
[email protected]
China| +0080 941 4610|
[email protected]
France| +33 563 825 319|
[email protected]
Germany| +492151-3280-100|
[email protected]
Japan| +0120 95 4886|
[email protected]
Middle East| +27 861 22 76 35|
[email protected]
Portugal| +800 913 174|
[email protected]
Spain| +33 563 825 319|
[email protected]
Other European, Middle Eastern, and African countries| +971 4 253 3218|
[email protected]
Other Countries not listed| +1 408 400 8495|
[email protected]
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)
Customer Name:|
---|---
Ship to Address:|
Phone Number:|
E-mail:|
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: ___
Xpert® Xpress Strep A
Legal Manufacturer is Sunnyvale with Single Registration Number (SRN) US-
MF-000010979.
Unique Device
Identifier (UDI)| Part Number| Batch Number| Lot Numbe|
Expiration Date
---|---|---|---|---
07332940006297| XPRSTREPA-CE-10| 1000613359| 23815| 26-Nov-23
07332940006372| XPRSTREPA-10| 1000413767| 10309| 21-May-23
07332940006372| XPRSTREPA-10| 1000470375| 23201| 23-Jul-23
07332940006372| XPRSTREPA-10| 1000478705| 23305| 30-Jul-23
07332940006372| XPRSTREPA-10| 1000482576| 23308| 06-Aug-23
07332940006372| XPRSTREPA-10| 1000489420| 23312| 13-Aug-23
07332940006372| XPRSTREPA-10| 1000492158| 23314| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000494468| 23315| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000494469| 23401| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000494470| 23402| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000494471| 23403| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000495394| 23404| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000495396| 23405| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000496223| 23406| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000496224| 23407| 20-Aug-23
07332940006372| XPRSTREPA-10| 1000501407| 23501| 27-Aug-23
07332940006372| XPRSTREPA-10| 1000501663| 23504| 27-Aug-23
07332940006372| XPRSTREPA-10| 1000502282| 23505| 27-Aug-23
07332940006372| XPRSTREPA-10| 1000502290| 23506| 27-Aug-23
07332940006372| XPRSTREPA-10| 1000506351| 23408| 03-Sep-23
07332940006372| XPRSTREPA-10| 1000507305| 23410| 03-Sep-23
07332940006372| XPRSTREPA-10| 1000508428| 23510| 03-Sep-23
07332940006372| XPRSTREPA-10| 1000510024| 23411| 10-Sep-23
07332940006372| XPRSTREPA-10| 1000514762| 23604| 17-Sep-23
07332940006372| XPRSTREPA-10| 1000514765| 23605| 17-Sep-23
07332940006372| XPRSTREPA-10| 1000514772| 23607| 17-Sep-23
07332940006372| XPRSTREPA-10| 1000516576| 23608| 17-Sep-23
07332940006372| XPRSTREPA-10| 1000518826| 23609| 17-Sep-23
07332940006372| XPRSTREPA-10| 1000519450| 23610| 17-Sep-23
07332940006372| XPRSTREPA-10| 1000520779| 23611| 17-Sep-23
07332940006372| XPRSTREPA-10| 1000520869| 23612| 17-Sep-23
07332940006372| XPRSTREPA-10| 1000522864| 23701| 24-Sep-23
07332940006372| XPRSTREPA-10| 1000522877| 23702| 24-Sep-23
07332940006372| XPRSTREPA-10| 1000527214| 23703| 24-Sep-23
07332940006372| XPRSTREPA-10| 1000527215| 23705| 24-Sep-23
07332940006372| XPRSTREPA-10| 1000527216| 23706| 24-Sep-23
07332940006372| XPRSTREPA-10| 1000535892| 23707| 08-Oct-23
07332940006372| XPRSTREPA-10| 1000535895| 23708| 08-Oct-23
07332940006372| XPRSTREPA-10| 1000535906| 23709| 08-Oct-23
07332940006372| XPRSTREPA-10| 1000535907| 23710| 08-Oct-23
07332940006372| XPRSTREPA-10| 1000535908| 23711| 08-Oct-23
07332940006372| XPRSTREPA-10| 1000542612| 23712| 08-Oct-23
07332940006372| XPRSTREPA-10| 1000543679| 23714| 08-Oct-23
07332940006372| XPRSTREPA-10| 1000544555| 23716| 15-Oct-23
07332940006372| XPRSTREPA-10| 1000544577| 23717| 15-Oct-23
07332940006372| XPRSTREPA-10| 1000552140| 23718| 22-Oct-23
07332940006372| XPRSTREPA-10| 1000552141| 23719| 22-Oct-23
07332940006372| XPRSTREPA-10| 1000552142| 23720| 22-Oct-23
07332940006372| XPRSTREPA-10| 1000560158| 23113| 29-Oct-23
07332940006372| XPRSTREPA-10| 1000566813| 23316| 29-Oct-23
07332940006372| XPRSTREPA-10| 1000605218| 23912| 26-Nov-23
07332940006372| XPRSTREPA-10| 1000693093| 24112| 14-Jan-24
07332940006372| XPRSTREPA-10| 1000753684| 23820| 11-Feb-24
07332940006372| XPRSTREPA-10| 1000757279| 24704| 18-Feb-24
07332940006372| XPRSTREPA-10| 1000763861| 24302| 18-Feb-24
07332940006372| XPRSTREPA-10| 1000778789| 24307| 25-Feb-24
07332940006372| XPRSTREPA-10| 1000784990| 24507| 03-Mar-24
07332940006372| XPRSTREPA-10| 1000785035| 24508| 03-Mar-24
07332940006372| XPRSTREPA-10| 1000785324| 24511| 03-Mar-24
07332940006372| XPRSTREPA-10| 1000799629| 23822| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000801610| 23823| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000801727| 23824| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000808180| 24512| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000808181| 24513| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000808182| 24514| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000808183| 23825| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000810140| 24313| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000810141| 24515| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000810317| 24516| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000810318| 24517| 10-Mar-24
07332940006372| XPRSTREPA-10| 1000823007| 24805| 17-Mar-24
904 CARIBBEAN DRIVE SUNNYVALE, CA 94089 USA
WWW.CEPHEID.COM
Confidential – Company Proprietary