CLASS II ONGOING Device recall · Reported 8 Nov 2023 · FDA Enforcement Report

Xpert Xpress Strep A, Xprstrepa recalled by Cepheid

Cepheid is recalling Xpert Xpress Strep A, Xprstrepa-10, distributed nationwide in the US. The recall was initiated on 24 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (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

Quantity recalled89,958 kits ( 10 test per kit)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0215-2024
FDA event ID: 93125
Recalling firm: Cepheid, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Apr 2023
FDA classified: 2 Nov 2023
Reported: 8 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

24 Apr 2023	Recall initiated by company
2 Nov 2023	Classified by FDA	+192 days
8 Nov 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.

Nationwide

Stores named: Walmart

Questions about this recall

Is Xpert Xpress Strep A, Xprstrepa-10 recalled?

Yes. Cepheid recalled Xpert Xpress Strep A, Xprstrepa-10 on 24 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-0215-2024.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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