Enforcement Letters to Industry
This section lists Warning Letters, Seizures, and Industry
Communication Letters related to In-vitro Diagnostic Devices.
Warning Letters
2005
Seizures
2004
| February
4, 2004 |
FDA requests the seizure of various neonatal chemistry and
isoelectric focusing diagnostic kits at PerkinElmer Life Sciences,
Inc., in Norton, Ohio |
2003
No items at this time
Industry Communication Letters
| July 28, 2004 |
In a Letter
to Manufacturers
of Antimicrobial Susceptibility Tests, FDA Clarified its Position
Regarding the Specific
Actions That Must be Taken to Minimize the Risk of Failing
to Reliably Detect Vancomycin Resistant S. aureus (VRSA). |
| July
19, 2004 |
FDA grants CLIA '88 waiver for the use of oral
fluid specimens with the OraQuick ADVANCE Rapid HIV-1/2 Antibody
Test. |
| July
12, 2004 |
In a letter FDA notified President and CEO of
Correlogic Systems, Inc. that OvaCheck™ test is subject
to FDA regulation and invited Correlogic to prepare a submission
for FDA review |
| March 18,
2004 |
FDA Recommends that Ventana Medical Systems Inc.
Submit a Premarket Approval Application (PMA) for Their Marketed
Automated INFORM® Human Papillomavirus (HPV) In-Situ Hybridization
(ISH) Diagnostic Test System |
| March 5, 2004 |
FDA and CMS invite the CEOs of Laboratory Corp.
of America and Quest Diagnostics to discuss the nature and appropriate
regulatory status of the OvaCheck - Ovarian Cancer Screen Test
Quest Diagnostics
Letter 
Lab Corporation
of American Letter |
| February
18, 2004 |
FDA invites President of Correlogic Systems,
Inc. to meet and discuss the regulatory status of their ovarian
cancer test. |
| December
18, 2003 |
FDA issues letter to Abbott Laboratories regarding
conformity with the Quality System Regulation, 21 CFR Part 820.
|
| December 4, 2003 |
FDA Issues Letters of Concern to Avitra Inc.,
Medimpex United Inc., Northwest Toxicology and Omega Laboratories,
Inc. Regarding the Marketing Status of Their Drug of Abuse
Testing Devices
Read Letter to Avitar
Inc.
Read Letter to Medimpex
United Inc.
Read Letter to Northwest
Toxicology
Read Letter to Omega Laboratories,
Inc. |
| November 4, 2003 |
OIVD Informs Roche that the AmpliChip Cannot
be Commercially Distributed Without an Appropriate Premarket
Determination from FDA |
|
