Z-1171-2016 Class II Terminated
FDA device recall Z-1171-2016 was initiated by Sekisui Diagnostics P.E.I. Inc. on January 22, 2016 and is designated Class II. Reason for recall: Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover The recall status is terminated (terminated August 9, 2016). Affected quantity: 14,407 kits..
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2016
- Initiation Date
- January 22, 2016
- Termination Date
- August 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,407 kits.
Product Description
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
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.
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