Beckman Coulter recalls specific bicarbonate reagents (OSR6137, OSR6237, OSR6637) that may produce falsely high bicarbonate results due to interference with Lactate Dehydrogenase in test samples. Affected units include certain lot numbers for each catalog code.
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Beckman Coulter is recalling specific bicarbonate reagents that can cause false high readings in blood tests. This happens because the reagent may interfere with Lactate Dehydrogenase in the test sample, leading to inaccurate results.
The bicarbonate reagent may interfere with Lactate Dehydrogenase (LDH) in the test sample, causing the analyzer to report falsely high bicarbonate levels. This could lead to incorrect medical diagnoses or treatment decisions if the test results are relied upon.
Users of Beckman Coulter AU analyzers who purchased the affected bicarbonate reagents (OSR6137, OSR6237, OSR6637) with specific lot numbers are most at risk. These reagents are used for quantitative bicarbonate testing in human serum and plasma.
Check the product label for catalog numbers OSR6137, OSR6237, or OSR6637. The affected units have specific lot numbers listed for each catalog code in the recall notice.
Look for catalog numbers OSR6137, OSR6237, or OSR6637 on the reagent packaging.
The bicarbonate reagent may generate falsely high results due to interference with Lactate Dehydrogenase in the test sample, which could lead to inaccurate medical testing.
The recall notice does not specify a remedy for this product. Check the product label for catalog numbers and lot numbers to determine if it is affected.
Affected lot numbers are listed in the recall notice: for OSR6137 (lots 2681-2690, 2693-2696), OSR6237 (lots 2702-2716), and OSR6637 (lots 2726, 2728-2739).
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0997-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0997-2026 from Beckman Coulter. 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.
