Z-0877-2022Class II

Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b...

Name: Z-0877-2022 Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b...
Creator: Hologic, Inc
Published: 2022-03-18
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2022-03-18 / Open, Classified

FDA source

Hologic, Inc began a recall of Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus on 2022-03-18. FDA classified it as Class II and gives the reason as "Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0877-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-18
Posted: 2022-04-06
Recalling firm: Hologic, Inc.
Product: Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Product code: NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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 root cause: Component change control
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]
Quantity in commerce: 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
Product codes and lots: UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0877-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0877-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-06

Product code NJR

K181156Class IPanther Fusion GBS AssayDiagenode / cleared 2018-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)