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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84634

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

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Event summary

Timeline bucket
January 03, 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

Vaginal Verification Panel Ref 8208 Lot 8208-11

Z-1096-2020
Recall number
Z-1096-2020
Initiated
January 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Microbiologics Inc
Quantity
9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.

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

Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.

Code information

Lot 8208-11

Distribution pattern

Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.