FDA Medical Device Recalls (openFDA)
Microbiologics Inc: MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303. (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)
- Recall number
- Z-0456-2008
- Recalling firm
- Microbiologics Inc
- Product
- MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303. (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)
- Status
- Terminated
- Initiated
- 2007-10-12
- Posted
- 2007-12-29
- Terminated
- 2008-06-26
- Reason
- Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.
- Root cause
- Employee error
- Action
- Consignees were initially notified of this recall by a telephone survey. An Urgent Product Recall letter was sent on 10/17/07 explaining the risk to patients. The firm sent replacements of the recalled product on 10/17/07 or 10/18/07, with request for acknowledgement of Recall Notification, and certification of disposal of incorrect product.
- Quantity
- 20
- Distribution
- Worldwide Distribution - USA including states of OR, PA, NY, RI, GA, SC, IL, PR, CA, AZ, and NJ, and countries of Japan, France, Colombia, and Brazil.
- Lot, serial or model codes
- Lot Number: 691295
- 510(k) numbers
- ["K861022"]
- PMA numbers
- not on file
- Product code
- JTR
- 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