FDA Device recall Z-1921-2015
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on…
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on… 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-1921-2015 |
| 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
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol 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: 04718917190; 03039773190; 05168538190; 03039773190. |
|---|
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-1921-2015%22
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