PML, Inc. dba Pml Microbiologicals Inc.
Wilsonville, OR
PML, Inc. dba Pml Microbiologicals Inc. appears in FDA device records in Wilsonville, OR. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 5
- Registered establishments
- 0
FDA records under these names
1 nameFDA records resolved to PML, Inc. dba Pml Microbiologicals Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Pml Microbiologicals Inc.recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0723-2008 | 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 | Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901). | Terminated | ||
| Z-0722-2008 | 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 | Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901). | Terminated | ||
| Z-0721-2008 | PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070 | Incorrect micro-organism-- Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901). | Terminated | ||
| Z-0011-2008 | Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates | Marketed a regulated product without a 510(k). | Terminated | ||
| Z-0014-2008 | Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174 | Plates manufactured without vancomycin. Possibility for false resistant results. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets PML, Inc. dba Pml Microbiologicals Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain