ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose &… — Class II medical device recall Z-1655-2016
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-1655-2016 |
|---|---|
| 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 | 74020, 74721 |
Product
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1655-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.