FDA Medical Device Recalls (openFDA)
PML, Inc. dba Pml Microbiologicals Inc.: 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
- Recall number
- Z-0722-2008
- Recalling firm
- PML, Inc. dba Pml Microbiologicals Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2007-10-15
- Posted
- 2008-02-15
- Terminated
- 2011-04-07
- 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
- 1 kit. Kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae)
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot # 185-1, Catalog # 201130 - Vitek NH ID Card (HHI) Set; Lot # 233851-1, Catalog # 101364 - LyfoCults Microorganism
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTR
- Firm FEI
- 3017344
- Firm city
- Wilsonville
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28