Roche recalls Elecs: BRAHMS PCT Immunoassay due to decreased patient sample recovery on certain analyzers. This may affect lab results accuracy. Affected units include specific lot numbers.
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
Roche is recalling its Elecsys BRAHMS PCT Immunoassay product because it shows lower recovery of patient samples when used with certain analyzers. This could lead to inaccurate lab results, which might impact medical decisions.
The product shows decreased recovery of patient samples when used with cobas e 801 modules compared to other analyzers. This means lab results might be less accurate, potentially affecting medical decisions.
Lab users who have the Elecsys BRAHMS PCT Immunoassay with lot number 204084 are affected. Healthcare professionals using this product for patient testing are most at risk.
Check for the Elecsys BRAHMS PCT Immunoassay with lot number 204084. This product is used for in vitro PCT testing in human serum and plasma.
Verify if your Elecsys BRAHMS PCT Immunoassay has lot number 204084.
The product shows decreased recovery of patient samples on the cobas e 801 module compared to other analyzers, which could lead to inaccurate lab results.
The recall record does not specify a remedy, so no action is required beyond checking if your product has the affected lot number.
The recall does not mention any risk of serious injury; the hazard is related to potential inaccurate lab results.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1311-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1311-2018 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.
