Accelerate Diagnostics recalls PhenoTest BC kit REF 10101018 with false positive results for Staphylococcus aureus and Streptococcus. Affected lot numbers: 5549A, 5566A, 5588A, 5606A, 5612A.
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 the PhenoTest BC kit with specific lot numbers because it can give false positive results for Staphylococcus aureus and Streptococcus. This could lead to incorrect bacterial identification, which might affect medical decisions.
The kit uses fluorescence in situ hybridization (FISH) probes that were improperly formulated in certain bulk lots. This causes false positive results for Staphylococcus aureus and Streptococcus species, potentially leading to incorrect bacterial identification.
Users of the Accelerate PhenoTest BC kit with lot numbers 5549A through 5612A are affected. Healthcare professionals and labs using this kit for bacterial identification are most at risk.
Check the lot numbers on the kit: 5549A, 5566A, 5588A, 5606A, or 5612A. The product is sold under the brand Accelerate Diagnostics with reference number 10101018.
Look for lot numbers 5549A, 5566A, 5588A, 5606A, or 5612A on the kit packaging.
The kit can produce false positive results for Staphylococcus aureus and Streptococcus species due to improperly formulated fluorescence probes in certain bulk lots.
Check the lot numbers on the kit. If it matches the affected lots (5549A, 5566A, 5588A, 5606A, 5612A), contact Accelerate Diagnostics for instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Accelerate Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0345-2023 — Accelerate Diagnostics Accelerate Diagnostics Hello, I own a Accelerate Diagnostics that is covered by recall Z-0345-2023 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.
