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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89329

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

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Event summary

Timeline bucket
December 20, 2021
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

API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.

Z-0525-2022
Recall number
Z-0525-2022
Initiated
December 20, 2021
Classification
Class II
Status
Terminated
Recalling firm
Biomerieux Inc
Quantity
462 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.

Code information

Model No. 32200; Lot 1008781060.

Distribution pattern

US (Domestic) Distribution to states of: AZ, IA, KY, and NY.