CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report

Panther Fusion GBS Assay Cartridges 96 Tests recalled by Hologic

Hologic is recalling Panther Fusion GBS Assay Cartridges 96 Tests, distributed in 21 states. The recall was initiated on 18 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353

Quantity recalled2061

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0877-2022
FDA event ID: 89855
Recalling firm: Hologic, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Mar 2022
FDA classified: 6 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

18 Mar 2022	Recall initiated by company
6 Apr 2022	Classified by FDA	+19 days
13 Apr 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA

Arkansas California Connecticut Florida Illinois Indiana Massachusetts Michigan New Hampshire New Jersey Nevada New York Oregon Pennsylvania Puerto Rico Tennessee Texas Utah Virginia Washington

Questions about this recall

Is Panther Fusion GBS Assay Cartridges 96 Tests recalled?

Yes. Hologic recalled Panther Fusion GBS Assay Cartridges 96 Tests on 18 Mar 2022. The recall is Class II and its status is Ongoing. Recall number Z-0877-2022.

Why was it 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.

Which lots are affected?

UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353

Where was it sold?

US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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