Accelerate Diagnostics recalls specific batches of PhenoTest BC kits due to false positive results for Staphylococcus aureus and Streptococcus. Affected kits may give incorrect infection results.
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.
Accelerate Diagnostics is recalling certain batches of the PhenoTest BC kit because they can produce false positive results for Staphylococcus aureus and Streptococcus. This means the test might incorrectly indicate an infection when there isn't one, leading to unnecessary treatments or delays in proper diagnosis.
The kit contains improperly formulated fluorescence probes that can cause false positive results. This means the test might show the presence of Staphylococcus aureus or Streptococcus bacteria when they are not actually present, leading to incorrect diagnoses.
Users of the PhenoTest BC kit who purchased it with the specific lot numbers listed in the recall are affected. Lab technicians and healthcare providers who rely on this test for bacterial identification are most at risk of incorrect results.
Check the lot numbers on the kit packaging: 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. The product was sold by Accelerate Diagnostics Inc.
Look for the specific lot numbers listed in the recall on the product packaging.
The kit contains improperly formulated fluorescence probes that can cause false positive results for Staphylococcus aureus and Streptococcus bacteria.
The recall does not specify a remedy, so contact Accelerate Diagnostics Inc directly for guidance.
Check the lot numbers on the packaging: 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.
We’ve drafted a message you can send Accelerate Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0346-2023 — Accelerate Diagnostics Accelerate Diagnostics Hello, I own a Accelerate Diagnostics that is covered by recall Z-0346-2023 from Accelerate Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
