Exact FDA event identifier

Event 84993

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

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Event summary

Timeline bucket: February 05, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: bioMerieux, 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

VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

Z-1534-2020

Recall number: Z-1534-2020
Initiated: February 05, 2020
Classification: Class II
Status: Terminated
Recalling firm: bioMerieux, Inc.
Quantity: 4,130 kits (82,600 cards)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

Code information

REF: 422024 Lot Number: 0210932204

Distribution pattern

International distribution in the countries of Germany and the Netherlands.