Exact FDA event identifier

Event 78731

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

Open FDA event record

Event summary

Timeline bucket: January 20, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Gibson Laboratories LLC

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

Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.

Z-0606-2018

Recall number: Z-0606-2018
Initiated: January 20, 2017
Classification: Class II
Status: Terminated
Recalling firm: Gibson Laboratories LLC
Quantity: 10/1 mL vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The firm information that the product was reporting false positive results

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm information that the product was reporting false positive results

Code information

Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.

Distribution pattern

Distributed to the states of AL, AZ & MS.