BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for p
FDA device recall Z-1043-2009 · posted 2009-03-31 · Terminated
Recall details
- Recalling firm
- Lexamed
- Reason for recall
- Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.
- Action taken
- The recalling firm contacted the customer and notified them of this recall via telephone on 1/13/2009, followed by an Urgent Product Recall Notice which was sent to the customer via Certified mail on 1/14/2009. The letter stated the problem with the affected lot and asked that the customer examine their inventory, remove the affected lot, and return the used and unused vial to LexaMed. The customer is to complete and return the enclosed acknowledgement card by mail or fax. Questions should be directed towards Anne Schuler, QA Manager at 419-693-5307 or by e-mail aschuler@lexamed.net.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LRF
- Quantity affected
- 1 vial
- Distribution
- USA: Utah
- Date initiated
- 2009-01-13
- Date posted
- 2009-03-31
- Date terminated
- 2009-12-09
- Location
- Toledo, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (K842579) | Biological & Environmental Control Laboratories | 1984-07-27 |