FDA Enforcement
Class II
Terminated
LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
Recall: Z-1927-2015
·
Reported July 8, 2015
Enforcement
- Recall Number
- Z-1927-2015
- Event ID
- 71182
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diagnostics Operations, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 8, 2015
- Initiation Date
- May 7, 2015
- Classification Date
- June 27, 2015
- Termination Date
- March 24, 2017
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025, United States
Description
LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
Reason
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
Code Info
Catalog numbers 04714423190; 04711220190; 05230438190; 05230446190.
Distribution
US (nationwide) including PR.
Quantity
6255