Z-0215-2024Class II

Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

Name: Z-0215-2024 Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Creator: Cepheid
Published: 2023-04-24
License: https://open.fda.gov/license/

Cepheid / initiated 2023-04-24 / Open, Classified / root cause: packaging

FDA source

Cepheid began a recall of Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only on 2023-04-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0215-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-24
Posted: 2023-11-02
Recalling firm: Cepheid
Product: Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Product code: PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Reason for recall: 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 tag: packaging
FDA 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 [email protected] 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 in commerce: 89,958 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.
Product codes and lots: UDI: (01)07332940006372/ Lots: 23718 23719 23720 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 23710 23711 23712 23714 23716 23717 23113 23316 23912 24112 23820 24704 24302 24307 24507 24508 24511 23822 23823 23824 24512 24513 24514 23825 24313 24515 24516 24517 24805

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0215-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0215-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-02
Z-0216-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-02

Product code PGX

K172126Class IIXpert Xpress Strep ACepheid / cleared 2017-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)