Z-0722-2008

PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of...

Name: Z-0722-2008 PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of...
Creator: PML, Inc. dba Pml Microbiologicals Inc.
Published: 2007-10-15
License: https://open.fda.gov/license/

PML, Inc. dba Pml Microbiologicals Inc. / initiated 2007-10-15 / Terminated / root cause: manufacturing process

FDA source

PML, Inc. dba Pml Microbiologicals Inc. began a recall of 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... on 2007-10-15. The reason FDA records is "Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0722-2008
Status: Terminated
Initiated: 2007-10-15
Posted: 2008-02-15
Terminated: 2011-04-07
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
Product code: JTR Kit, Quality Control For Culture Media
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).
Root cause tag: manufacturing process
FDA 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 in commerce: 1 kit. Kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae)
Distribution: Nationwide Distribution
Product codes and lots: Lot # 185-1, Catalog # 201130 - Vitek NH ID Card (HHI) Set; Lot # 233851-1, Catalog # 101364 - LyfoCults Microorganism

Product code JTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)