Abbott recalls specific ARCHITECT Magnesium test kits that may give inaccurate low results for magnesium in urine. Affected kits have lot numbers listed in the recall notice.
Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.
Abbott is recalling certain ARCHITECT Magnesium test kits that may produce falsely low magnesium results in urine tests. This could lead to incorrect health assessments if used without knowing the issue.
The test kits may show lower magnesium levels than actual in urine samples, especially when results exceed 0.5mEq/L. This could cause inaccurate health assessments if the test is used without knowing the issue.
People using the specific ARCHITECT Magnesium test kits with the listed lot numbers for urine magnesium testing are affected. Those with the kits may need to check results carefully.
Check the lot numbers on the test kit packaging. Affected kits have specific lot numbers listed in the recall notice, such as 36338UN17 or 97389UN17.
Look for the lot number on the test kit packaging, which should match the numbers listed in the recall notice.
Abbott internal testing found that these kits may give falsely low magnesium results in urine tests, especially for samples over 0.5mEq/L.
No, but you should check the lot number to see if your kit is affected. If it is, you may want to verify results with another test.
Check the lot number on your test kit packaging against the list of affected numbers provided in the recall notice.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0971-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0971-2019 from Abbott. 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.
