PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070
FDA Recall Z-0722-2008 · Posted 2008-02-15
Recalling FirmPML, Inc. dba Pml Microbiologicals Inc.
Recall StatusTerminated
Product CodeJTR
Date Initiated2007-10-15
Date Terminated2011-04-07
Product Quantity1 kit. Kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae)
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).
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.