Roche Diagnostics Operations, Inc. Recall: HDL-Cholesterol gen.3. For the quantitative det
Roche Diagnostics Operations, Inc. Recall: HDL-Cholesterol gen.3. For the quantitative det is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Roche Diagnostics Operations, Inc.; Product: HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL
| Recalling firm | Roche Diagnostics Operations, Inc. |
|---|---|
| Product | HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US (nationwide) including PR. |
| Recall initiated | 20150507 |
| Recall number | Z-1924-2015 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
Try RecallGuard →