PlainRecalls
FDA Devices Moderate Class II Terminated

Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.

Reported: July 8, 2015 Initiated: May 7, 2015 #Z-1930-2015

Product Description

Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.

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?
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.. 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-1930-2015.