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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89379

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

Open FDA event record

Event summary

Timeline bucket
February 24, 2021
Product types
Device
Classifications
Class III
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

KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.

Z-0543-2022
Recall number
Z-0543-2022
Initiated
February 24, 2021
Classification
Class III
Status
Terminated
Recalling firm
Microbiologics Inc
Quantity
65 packs (130 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.

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

Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.

Code information

Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486

Distribution pattern

Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.