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Terminated

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

FDA Recall Z-0723-2008 · Posted 2008-02-15

Recalling FirmPML, Inc. dba Pml Microbiologicals Inc.
Recall StatusTerminated
Product CodeJTR
Date Initiated2007-10-15
Date Terminated2011-04-07
Product Quantity5 kits. Each kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae) for a total of 25 vials.

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.

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