Recall Z-0877-2022
Hologic, Inc · initiated March 18, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Codes / lots: UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
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.
FDA-determined cause: Component change control
Action taken
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 molecularsupport@hologic.com
Details
- Recall number
- Z-0877-2022
- Initiated
- March 18, 2022
- Posted by FDA
- April 6, 2022
- Product code
- NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- Quantity
- 2061
- 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
- Recalling firm
- Hologic, Inc, San Diego, CA