ADVIA CHEMISTRY ENZYMATIC CREATININE_2 — Class II medical device recall Z-1654-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-05-18, distributed nationwide. Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interferen
| Recall number | Z-1654-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2016-03-17 |
| Classified | 2016-05-11 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 137,422 units |
| Model numbers | 74330 |
Product
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
Reason for recall
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
Machine access
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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.