Z-1096-2020Class II

Vaginal Verification Panel Ref 8208 Lot 8208-11

Name: Z-1096-2020 Vaginal Verification Panel Ref 8208 Lot 8208-11
Creator: Microbiologics Inc
Published: 2020-01-03
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2020-01-03 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of Vaginal Verification Panel Ref 8208 Lot 8208-11 on 2020-01-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1096-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Posted: 2020-02-05
Terminated: 2020-09-16
Recalling firm: Microbiologics, Inc.
Product: Vaginal Verification Panel Ref 8208 Lot 8208-11
Product code: OHQ Multi-Analyte Controls Unassayed
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Letters will be sent via email to all consignees and end users regarding the correction. Users are to review the instructions, determine how the information affects their usage, and upon determination either use with new information or discard the product.
Quantity in commerce: 9
Distribution: Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
Product codes and lots: Lot 8208-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1096-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1096-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)