Reported Nov 8, 2023 · Ongoing
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Cepheid
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cepheid · 904 E Caribbean Dr · Sunnyvale, CA · 94089-1189
Is this the product you have?
- Xpert Xpress Strep A, XPRSTREPA-10
- P/N302-2294 IVD, Rx Only
- Lot codes and dates
- UDI(01)07332940006372/
- Lots
70 of 70 codes
237182371923720103092320123305233082331223314233152340123402234032340423405234062340723501235042350523506234082341023510234112360423605236072360823609236102361123612237012370223703237052370623707237082370923710237112371223714237162371723113233162391224112238202470424302243072450724508245112382223823
- Amount recalled
- 89,958 kits ( 10 test per kit)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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