Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Re
Summary
The FDA issued a Class II for Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26 by Hologic, Inc.. Reason: Use of assay along with plasma specimen may result in error code which would invalidate sample..
Details
Source
Device Recall
External ID
Z-1371-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
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.
Lot/Code Info: Lot #: 402941/ UDI:15420045514553
Quantity Affected: 684 kits
Reason for Recall
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Distribution
Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL, MD, MI, MO, TN, TX, WI and the countries of Australia, Germany, Denmark, Spain, France, Great Britain, Italy, Norway, Qatar, Sweden.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-14
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hologic, Inc. has 41 FDA actions in our database, including 22 recalls and 19 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hologic, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hologic, Inc. have FDA actions?
Hologic, Inc. has 41 FDA actions in our database, including 22 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1371-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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