FDA Medical Device Recalls (openFDA)
Cepheid: Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD
- Recall number
- Z-0216-2024
- Recalling firm
- Cepheid
- Product
- Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
- Status
- Open, Classified
- Initiated
- 2023-04-24
- Posted
- 2023-11-02
- Terminated
- not on file
- Reason
- pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
- Root cause
- Unknown/Undetermined by firm
- Action
- On April 28, 2023, Cepheid issued a Important product recall notification to affected consignees via FedEx. In addition to informing consignees about the recall, Cepheid ask consignees to take the following action: 2. 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. 3. 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 CFQ@cepheid.com or faxed to +1 (408) 716-3143. 4. 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.
- Quantity
- 1,413 kits ( 10 test per kit)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.
- Lot, serial or model codes
- UDI: (01)07332940006297/ Lot: 23815
- 510(k) numbers
- ["K172126"]
- PMA numbers
- not on file
- Product code
- PGX
- Firm FEI
- 3004530258
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28