Aptima CMV Quant Assay Recalled for Invalid Results with Plasma Specimens
Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a diagnostic test that may produce invalid results when used with plasma specimens, presenting risk of diagnostic error; however, no illnesses or injuries have been reported.
Plain-English summary
Hologic, Inc. is recalling 684 kits of the Aptima CMV Quant Assay, a diagnostic test used to quantify cytomegalovirus (CMV). The affected kits include reference numbers AW-22600-001, AW-25509-001, and AW-26381-001.
When the assay is used with plasma specimens, the test may generate an error code that invalidates the sample result. This renders the test unable to produce a reliable result for the specimen being tested.
The recalled kits have been distributed worldwide. In the United States, affected kits reached healthcare facilities in California, Connecticut, Florida, Idaho, Illinois, Maryland, Michigan, Missouri, Tennessee, Texas, and Wisconsin. Internationally, kits were distributed to Australia, Germany, Denmark, Spain, France, Great Britain, Italy, Norway, Qatar, and Sweden. The affected lot number is 402941 (UDI 15420045514553).
This is a Class II FDA recall issued as Z-1371-2024. Hologic, Inc. is the recalling manufacturer.
The recalled product
- Product
- Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent…
- Manufacturer
- Hologic, Inc.
- Affected units
- 684
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 402941/ UDI:15420045514553
Distribution
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