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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92878

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

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Event summary

Timeline bucket
August 14, 2023
Product types
Device
Classifications
Class III
Statuses
Ongoing
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, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

Z-2576-2023
Recall number
Z-2576-2023
Initiated
August 14, 2023
Classification
Class III
Status
Ongoing
Recalling firm
Microbiologics Inc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

Code information

UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024

Distribution pattern

US Nationwide distribution in the states of MN, PA, TN, TX.