Reported Apr 13, 2022 · Ongoing
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- Panther Fusion GBS Assay Cartridges 96 Tests
- Catalog NumberPRD-04484. in vitro diagnostic test for group b streptococcus
- Lot codes and dates
- UDI15420045510890
- Lot numbers
274954284599296991300796309230309353
- Amount recalled
- 2061
Where it was sold
Why it was recalled
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
This product could cause temporary or reversible health problems — stop using it.
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