Hologic recalls Aptima CMV Quant Assay reagents (AW-22600-001, AW-25509-001, AW-26381-001) due to potential error codes when used with plasma specimens. Affected units may invalidate samples.
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Hologic is recalling specific Aptima CMV Quant Assay reagents because using them with plasma specimens can cause error codes that invalidate samples. This affects lab users who rely on accurate test results.
The reagents may produce error codes when combined with plasma specimens, which can invalidate the test results. This means the sample might not be counted as valid for CMV testing.
Lab technicians and healthcare providers using the recalled reagents for CMV testing. Those who have plasma specimens in their testing process are most at risk.
Check for reference numbers AW-22600-001, AW-25509-001, or AW-26381-001 on the reagent packaging. The lot number 402941 or UDI 15420045514553 may also indicate the affected units.
Look for reference numbers AW-22600-001, AW-25509-001, or AW-26381-001 on the reagent packaging.
The reagents may produce error codes when used with plasma specimens, which can invalidate the test results.
Check for reference numbers AW-22600-001, AW-25509-001, or AW-26381-001 on the reagent packaging. The lot number 402941 or UDI 15420045514553 may also indicate the affected units.
The recall does not specify a remedy, so contact Hologic directly for guidance.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-1371-2024 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-1371-2024 from Hologic. 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.
