MULTIGENT Acetaminophen for use with Architect/Aeroset Cat — Class II medical device recall Z-1902-2012
Terminated recall by Sekisui Diagnostics Llc, reported 2012-07-04, distributed in IL. Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic contro
| Recall number | Z-1902-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sekisui Diagnostics Llc, Framingham, MA, United States |
| Recall initiated | 2012-05-29 |
| Classified | 2012-06-27 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2012-11-14 |
| Distributed | IL |
| Quantity | 1,600 kits |
| Lot numbers | 2013-01, 41928UQ11 |
| Model numbers | 2K99-20 |
Product
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Reason for recall
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
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-1902-2012. 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.