Beckman Coulter recalls specific SYNCHRON Systems Phosphorus reagent lots that may fail calibration before expiration, causing delays in patient test results. Affected lots include M309642, M309641, etc. Contact for remedy.
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
Beckman Coulter is recalling specific lots of SYNCHRON Systems Phosphorus reagents that may fail calibration before their expiration date, which can delay patient test results. This affects healthcare facilities using these reagents for in vitro diagnostics.
The reagent lots may fail calibration before the expiration date, leading to delays in obtaining patient test results. This is a calibration issue that does not pose a direct safety risk to users but affects diagnostic timing.
Healthcare facilities using the recalled SYNCHRON Systems Phosphorus reagents for in vitro diagnostics. Patients may experience delayed test results if their facility uses the affected lots.
Check the lot numbers on the reagent container: M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M410513, M412278. The product is sold for in vitro diagnostic use with a prescription.
Verify the lot number on the reagent container to see if it matches the affected lots listed: M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M410513, M412278.
The recalled reagent lots may fail calibration before the expiration date, causing delays in patient test results.
Affected lot numbers include M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M410513, and M412278.
No, the recall does not require stopping use; it only affects calibration timing for patient results.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0071-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0071-2026 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.
