Reported Dec 7, 2022 · Ongoing
Accelerate PhenoTest BC kit REF 10102018
Accelerate Diagnostics Inc.
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: Accelerate Diagnostics Inc · 3950 S Country Club Rd Ste 470 · Tucson, AZ · 85714-2240
Is this the product you have?
- Accelerate PhenoTest BC kit REF 10102018
- Lot codes and dates
- Part Number10102018
- UDI-DI Code00862011000369
- Lot Numbers
5559A5556A5555A5554A5553A5551A5550A5548A5546A5557A5558A5560A5561A5562A5563A5564A5567A5568A5570A5571A5572A5574A5578A5579A5580A5583A5577A5576A5581A5582A5585A5586A5587A5589A5590A5591A5592A5594A5595A5596A5597A5598A5599A5601A5602A5603A5604A5607A5608A5610A5611A5613A5614A
- Amount recalled
- 7,160 kits
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
Why it was recalled
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
This product could cause temporary or reversible health problems — stop using it.
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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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