Microgenics recalls QMS Tacrolimus calibrators that may over-quantitate tacrolimus patient results, leading to inaccurate medication levels. Affected units include specific model numbers and lot numbers.
Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.
Microgenics is recalling QMS Tacrolimus calibrator sets that can cause over-quantitation in patient tacrolimus test results. This means the test might show higher medication levels than actual, risking incorrect dosing decisions.
The calibrators recover between 82% to 94% of target values, causing the test to overestimate tacrolimus levels. This can lead to incorrect dosing decisions if the test shows higher medication levels than actually present.
Patients using the QMS Tacrolimus Immunoassay test with the recalled calibrators may receive inaccurate medication level readings. Healthcare providers who use these calibrators for tacrolimus testing are most at risk.
Check for the model numbers 10015566-3 through 10015571-3 on the calibrators. Affected units have lot numbers 74175462 or 74267412 and UDI codes starting with (01) 0884883 01259 2.
Look for model numbers 10015566-3 through 10015571-3 on the calibrators.
The calibrators recover between 82% to 94% of target values, causing over-quantitation in tacrolimus patient results.
It means the test may show higher tacrolimus levels than actually present, potentially leading to incorrect dosing decisions.
Check for model numbers 10015566-3 through 10015571-3 and lot numbers 74175462 or 74267412.
We’ve drafted a message you can send Microgenics to request your refund or repair — edit it as you like.
Subject: Recall Z-1284-2022 — Microgenics Microgenics Hello, I own a Microgenics that is covered by recall Z-1284-2022 from Microgenics. 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.
