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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89513

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

Open FDA event record

Event summary

Timeline bucket
July 17, 2015
Product types
Device
Classifications
Class III
Statuses
Completed
Recalling firm wording
Microbiologics 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

LYFO Disk

Z-0788-2022
Recall number
Z-0788-2022
Initiated
July 17, 2015
Classification
Class III
Status
Completed
Recalling firm
Microbiologics Inc
Quantity
3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

Code information

Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)

Distribution pattern

Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.