Recall Z-1043-2009 ยท LRF Candida Spp., Direct Antigen, Id
Lexamed
BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose.
| Date | Mar 31, 2009 (initiated Jan 13, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1 vial |
| Distribution | USA: Utah |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842579 | B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS Biological & Environmental Control Laboratories, Jul 27, 1984 |