LDL-Cholesterol plus gen — Class II medical device recall Z-1928-2015
Terminated recall by Roche Diagnostics Operations, Inc., reported 2015-07-08, distributed nationwide. Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trin
| Recall number | Z-1928-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2015-05-07 |
| Classified | 2015-06-27 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 6,255 |
| Model numbers | 05401682190 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1928-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.