---
title: "Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in v... — FDA record Z-0877-2022 | Is It on Recall"
description: "Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results."
url: https://isitonrecall.com/recall/fda-device-z-0877-2022-panther-fusion-gbs-assay-cartridges-96-tests-catalog-number-prd-04484-in-vitro-diagnostic-test-for-g/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b strepto... — FDA record Z-0877-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 18, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
- **Reason**: Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
- **Classification**: Class II
- **Recalling firm**: Hologic, Inc
- **Quantity**: 2061
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0877-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0877-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353 |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [California](https://isitonrecall.com/state/california/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [New Hampshire](https://isitonrecall.com/state/new-hampshire/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Washington](https://isitonrecall.com/state/washington/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)

## Dates in the source

- **Report date**: Apr 13, 2022
- **Recall initiation date**: Mar 18, 2022
- **Center classification date**: Apr 6, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0877-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Hologic, Inc records](https://isitonrecall.com/brand/hologic-inc/)