Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptoco
Summary
The FDA issued a Class II for Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vit by Hologic, Inc. Reason: Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results..
Details
Source
Device Recall
External ID
Z-0877-2022
Action Date
2022-04-13
Status
Ongoing
Category
device
Product Description
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Lot/Code Info: UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
Quantity Affected: 2061
Reason for Recall
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Distribution
US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-18
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 149 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-0877-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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