Recall Z-0456-2008
Microbiologics Inc · initiated October 12, 2007
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)
Codes / lots: Lot Number: 691295
Reason for recall
Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0456-2008
- Initiated
- October 12, 2007
- Posted by FDA
- December 29, 2007
- Terminated
- June 26, 2008
- Product code
- JTR – Kit, Quality Control For Culture Media
- 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.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN