FDA Device recall Z-1622-2015
Homocysteine test system - Homocysteine Reagent. 05385415190
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of Homocysteine test system - Homocysteine Reagent. 05385415190 by Roche Diagnostics Operations, citing customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1622-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-23 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
Reason
Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di
Identifiers
| code_info | 05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101 |
|---|
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-1622-2015%22
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