ADVIA Chemistry Acetaminophen reagents — Class II medical device recall Z-2416-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-08-26, distributed nationwide. A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry S
| Recall number | Z-2416-2015 |
|---|---|
| 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 | 2015-06-30 |
| Classified | 2015-08-19 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BH, CA, CZ, DE, ES, FI, FR, GB, IL, IT, NL, NO, PL, PT, SE, TR |
| Quantity | 1,032 |
| Reason classes | potency |
| Lot numbers | 46251, 46369, 46370, 46564, 46619, 46782, 47001, 47157, 47558 |
| Model numbers | 07989138 |
| Expiration dates | 2015-06-30 |
Product
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
Reason for recall
A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.
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-2416-2015. 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.