Exact FDA event identifier

Event 89855

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: March 18, 2022
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Hologic, Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0877-2022

Recall number: Z-0877-2022
Initiated: March 18, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Hologic, Inc
Quantity: 2061

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

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Inspect official wording and provenance

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.

Code information

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

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