MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud,
FDA device recall Z-0456-2008 · posted 2007-12-29 · Terminated
Recall details
- Recalling firm
- Microbiologics Inc
- Reason for recall
- Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JTR
- Quantity affected
- 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.
- Date initiated
- 2007-10-12
- Date posted
- 2007-12-29
- Date terminated
- 2008-06-26
- Location
- Saint Cloud, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |