FDA Medical Device Recalls (openFDA)
Microbiologics Inc: Vaginal Verification Panel Ref 8208 Lot 8208-11
- Recall number
- Z-1096-2020
- Recalling firm
- Microbiologics Inc
- Product
- Vaginal Verification Panel Ref 8208 Lot 8208-11
- Status
- Terminated
- Initiated
- 2020-01-03
- Posted
- not on file
- Terminated
- 2020-09-16
- Reason
- 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
- 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
- 9
- Distribution
- Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
- Lot, serial or model codes
- Lot 8208-11
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHQ
- Firm FEI
- 2150138
- Firm city
- Saint Cloud
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28