Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay — Class II medical device recall Z-1171-2016
Terminated recall by Sekisui Diagnostics P.E.I. Inc., reported 2016-03-23, distributed in AZ, CA, FL, IA, ID, IL, MA, MN…. Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under re
| Recall number | Z-1171-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sekisui Diagnostics P.E.I. Inc., Charlottetown, Canada |
| Recall initiated | 2016-01-22 |
| Classified | 2016-03-14 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2016-08-09 |
| Distributed | AZ, CA, FL, IA, ID, IL, MA, MN, MT, ND |
| Countries outside the US | CA, FR, HK |
| Quantity | 14,407 kits |
| Lot numbers | 47649, 47650, 47662, 47663, 47677, 47694, 47695, 48253, 48294, 48385, 48386 |
| Model numbers | 506-10, 506-30 |
Product
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Reason for recall
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
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-1171-2016. 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.