PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp
FDA device recall Z-0723-2008 · posted 2008-02-15 · Terminated
Recall details
- Recalling firm
- PML, Inc. dba Pml Microbiologicals Inc.
- Reason for recall
- Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JTR
- Quantity affected
- 5 kits. Each kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae) for a total of 25 vials.
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-10-15
- Date posted
- 2008-02-15
- Date terminated
- 2011-04-07
- Location
- Wilsonville, OR
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