Roche recalls cobas c 503 analyzers for inaccurate therapeutic drug monitoring results due to residual reagent transfer during testing. Affected units have specific catalog numbers.
During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
Roche is recalling cobas c 503 analyzers used in clinical labs because they can give inaccurate therapeutic drug monitoring results. This could lead to incorrect medication dosing if the analyzer is not fixed.
During testing, residual reagent can sometimes transfer from the conus into the reaction cuvette. This causes the analyzer to show inaccurate low results for certain therapeutic drug monitoring tests.
Clinical lab users who own or operate cobas c 503 analyzers with the listed catalog numbers. Lab technicians and healthcare providers are most at risk of incorrect medication dosing.
Check if your analyzer has catalog numbers 08445605190, 08445567190, 08253153190, or 08058580190. These are specific models of the cobas c 503 analyzer used in clinical labs.
Identify if your analyzer has the catalog numbers 08445605190, 08445567190, 08253153190, or 08058580190.
The analyzer can give inaccurate therapeutic drug monitoring results due to residual reagent transfer during testing.
Check if your analyzer has the specific catalog numbers listed. If it does, contact Roche for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0752-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0752-2021 from Roche. 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.
