FDA Device recall Z-1171-2016
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalo…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalo… by Sekisui Diagnostics P E I, citing crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1171-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-22 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sekisui Diagnostics P E I |
| Distribution | AZ, CA, FL, IA, ID, IL, MA, MN, MT, ND |
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
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Identifiers
| code_info | Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1171-2016%22
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