CLASS II ONGOING Device recall · Reported 8 Nov 2023 · FDA Enforcement Report
Xpert Xpress Strep recalled by Cepheid
Cepheid is recalling Xpert Xpress Strep A, 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
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-0216-2024
- 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, REF:Xprstrepa-CE-10, CE IVD,
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.
Questions about this recall
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)07332940006297/ Lot: 23815
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93125| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Xpert Xpress Strep A, Xprstrepa recalled by Cepheid | Cepheid | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Xpert¿ Bcr-abl Ultra recalled by Cepheid | Cepheid | Labeling Errors | 27 states |
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