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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Accelerate Diagnostics Inc: 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.

Agency Publication Date: December 6, 2022
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Affected Products

Product: Accelerate PhenoTest BC kit REF 10101018

Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A

Lot Numbers:
00862011000307
Numbers
Product: Accelerate PhenoTest BC kit REF 10102018

Part Number: 10102018 UDI-DI Code: 00862011000369 Lot Numbers: 5559A 5556A 5555A 5554A 5553A 5551A 5550A 5548A 5546A 5557A 5558A 5560A 5561A 5562A 5563A 5564A 5567A 5568A 5570A 5571A 5572A 5574A 5578A 5579A 5580A 5583A 5577A 5576A 5581A 5582A 5585A 5586A 5587A 5589A 5590A 5591A 5592A 5594A 5595A 5596A 5597A 5598A 5599A 5601A 5602A 5603A 5604A 5607A 5608A 5610A 5611A 5613A 5614A

Lot Numbers:
00862011000369
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91075
Status: Active
Manufacturer: Accelerate Diagnostics Inc
Manufactured In: United States
Units Affected: 2 products (200 kits; 7,160 kits)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.