Device 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.
Z-1171-2016
Product summary
- Event
- Event 73129
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,407 kits.
- Official record key
device-enforcement:Z-1171-2016
Official wording
Reason: Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Code information: Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294
Distribution pattern: Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
Derived failure modes
-
Unknown
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover