FDA Device recall Z-1664-2016
Dimension Vista Assays: Enzymatic Creatine (ECRE)
- FDA Device
- Class II
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of Dimension Vista Assays: Enzymatic Creatine (ECRE) by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1664-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-17 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista Assays: Enzymatic Creatine (ECRE)
Reason
Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
Identifiers
| code_info | Device Listing: D089144 Enzymatic Creatinine (ECRE), Catalog # K1270A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1664-2016%22
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