Recall Z-0723-2008 ยท JTR Kit, Quality Control For Culture Media
PML, Inc. dba Pml Microbiologicals Inc.
PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070
| Date | Feb 15, 2008 (initiated Oct 15, 2007) |
| Status | Terminated |
| Reason | Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901). |
| Root cause | Mixed-up of materials/components |
| Action | On 10/15/2007, firm notified consignees by telephone. A follow up letter dated 10/26/07, was faxed to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material. Consignees were requested to fax back response indicating the amount of product they had on hand at time of notification. |
| Quantity | 5 kits. Each kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae) for a total of 25 vials. |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.