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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93801

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

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Event summary

Timeline bucket
January 08, 2024
Product types
Device
Classifications
Class II
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

Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.

Z-1075-2024
Recall number
Z-1075-2024
Initiated
January 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Microbiologics Inc
Quantity
580 packages

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
contaminated with one of the positive control pathogens (Norovirus

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.

Code information

Lot #8184-68, Exp. 5/31/2025, UDI-DI 70845357041448. UPDATE: The recall was expanded on 1/23/2024 to include the following additional lot numbers: 8184-65, exp. 3/31/2025; 8184-66, exp. 4/30/2025; 8184-67, exp. 5/31/2025; 8184-69, exp. 6/30/2025; 8184-70, exp. 8/31/2025; and 8184-71, exp. 8/31/2025.

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, and WY. There was government distribution and no military distribution. Foreign distribution was made to France.