Recall Z-1927-2015— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2015-05-07, terminated 2017-03-24. It names one FDA 510(k) clearance: K012287. Product: 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..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-07
- Terminated
- 2017-03-24
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.