Recall Z-1371-2024— Hologic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc., initiated 2023-09-14. FDA's recall record names no specific 510(k) clearance for this event. 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, Reconstitution Collars.. Reason: Use of assay along with plasma specimen may result in error code which would invalidate sample..
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-14
- Firm location
- San Diego, CA, United States
Product description
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, Reconstitution Collars.
Reason for recall
Use of assay along with plasma specimen may result in error code which would invalidate sample.
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