Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
FDA Recall Z-0877-2022 · Posted 2022-04-06
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Recalling FirmHologic, Inc
Recall StatusOpen, Classified
Product CodeNJR
Date Initiated2022-03-18
Product Quantity2061
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.
Firm Action
On 03/18/22, recall notices were sent to customers who were informed that the recalling firm is discontinuing the further sale of the affected GBS Assay for the foreseeable future.
Customers were asked to do the following:
1) Discontinue use and destroy affected GBS assay kit lots and respective components.
2) Complete and return the customer response form.
Customers with additional questions were encouraged to contact Technical Support at +1 888 484 4747 or +1 858 410 8511 between 5am PDT and 5 pm PDT, or by email at [email protected]
Root Cause
Component change control
Distribution Pattern
US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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