Roche Diagnostics Operations, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1925-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.

Product Classification:

Class II

Date Initiated: May 7, 2015

Date Posted: July 8, 2015

Recall Number: Z-1925-2015

Event ID: 71182

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.

Status: Terminated

Product Quantity: 6255

Code Information:

Catalog Numbers: 05401488190; 0439980319; 05168805190; 04399803190, 04878205160.

Distribution Pattern:

US (nationwide) including PR.

Voluntary or Mandated:

Voluntary: Firm initiated