PlainRecalls
FDA Devices Moderate Class II Terminated

LDL-Cholesterol plus 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.

Reported: July 8, 2015 Initiated: May 7, 2015 #Z-1928-2015

Product Description

LDL-Cholesterol plus 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 for Recall

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.

Details

Units Affected
6255
Distribution
US (nationwide) including PR.
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
LDL-Cholesterol plus 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.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 6255.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1928-2015.