Siemens Healthcare recalls Centaur CA 125II Assay kits with specific lot numbers due to potential over-recovery in patient samples during testing.
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Siemens Healthcare is recalling certain Centaur CA 125II Assay kits because some patient samples may show over-recovery when diluted, which could lead to inaccurate test results. This affects laboratory users who rely on these kits for cancer marker testing.
The assay may cause patient samples to show over-recovery outside the expected range when diluted, potentially leading to inaccurate cancer marker test results. This issue occurs with specific lot numbers of the assay kits.
Laboratory users who have the recalled Centaur CA 125II Assay kits with specific lot numbers. Those performing cancer marker tests using these kits are most at risk of inaccurate results.
Check for lot numbers 71804174, 73838174, 88601174, 94549174, 23904176, 24439176, 31842176, 42051176, 54008176 (expiring April 2018) or 71229174, 73455174, 84113174, 91568174, 23903176, 24944176, 41442176, 46735176 (expiring August 2018).
Identify the lot number on the assay kit packaging to determine if it is recalled.
Siemens Healthcare is recalling specific Centaur CA 125II Assay kits with certain lot numbers due to potential over-recovery in patient samples during testing.
Check the lot numbers listed in the recall notice: 71804174, 73838174, 88601174, 94549174, 23904176, 24439176, 31842176, 42051176, 54008176 (expiring April 2018) or 71229174, 73455174, 84113174, 91568174, 23903176, 24944176, 41442176, 46735176 (expiring August 2018).
The recall does not specify a remedy, so no action is required beyond checking if your kit is listed.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1486-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1486-2018 from Siemens Healthcare. 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.
