Accelerate Diagnostics recalls PhenoTest BC kits with specific lot numbers due to potential false positives for Staphylococcus aureus. Affected kits may give incorrect results, but no remedy is specified in the recall notice.
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Accelerate Diagnostics is recalling specific batches of their PhenoTest BC kits because they might produce false positive results for Staphylococcus aureus. This could lead to incorrect health assessments if used improperly.
The kits may generate false positive results for Staphylococcus aureus identification, which could lead to incorrect health assessments. This happens due to a potential issue with the test's accuracy in detecting the bacteria.
Users of the Accelerate PhenoTest BC kit with lot numbers 2880A, 2885A, 2886A, or 2887A are affected. Healthcare professionals and labs using these kits for Staphylococcus aureus testing are most at risk.
Check the lot number on the kit label. Affected kits have lot numbers 2880A, 2885A, 2886A, or 2887A, all with an expiration date of September 18, 2018.
Look for the lot number on the kit label to determine if it is affected (2880A, 2885A, 2886A, or 2887A).
The kits may produce an elevated rate of false positive calls for Staphylococcus aureus identification.
Lot numbers 2880A, 2885A, 2886A, and 2887A, all with an expiration date of September 18, 2018.
The recall notice does not specify any remedy.
We’ve drafted a message you can send Accelerate Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1529-2018 — Accelerate Diagnostics Accelerate Diagnostics Hello, I own a Accelerate Diagnostics that is covered by recall Z-1529-2018 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.
