Exact FDA event identifier

Event 73585

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

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Event summary

Timeline bucket: February 24, 2016
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 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. 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. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Z-1596-2016

Recall number: Z-1596-2016
Initiated: February 24, 2016
Classification: Class II
Status: Terminated
Recalling firm: Biomerieux Inc
Quantity: 337 Kits of 20 Cards/Kit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

Code information

Lot/Serial: 485368220 Expiry: 12-JAN-17

Distribution pattern

Worldwide Distribution to China Taiwan region; No US/military/government distribution.