FDA Device recall Z-1928-2015

LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-densi…

FDA Device
Class II
terminated
Published 2015-07-08

On 2015-07-08 the FDA classified a Class II recall of LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-densi… by Roche Diagnostics Operations, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1928-2015
Classification	Class II
Status	terminated
Initiated	2015-05-07
Published	2015-07-08
Last updated	2026-09-13 11:53 UTC
Company	Roche Diagnostics Operations
Distribution	US

Product

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

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.

Identifiers

code_info	Catalog Numbers 05401682190; 03038866322; 05171369190; 03038866322.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1928-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.