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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86574

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

Open FDA event record

Event summary

Timeline bucket
October 08, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.

Z-0402-2021
Recall number
Z-0402-2021
Initiated
October 08, 2020
Classification
Class II
Status
Terminated
Recalling firm
Microbiologics Inc
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

Code information

Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.