Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K recall
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number…
Why was Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K recalled?
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294
- 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…
- Recalling firm
- Sekisui Diagnostics P.E.I. Inc.
- Quantity
- 14,407 kits.
- Distribution
- 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.
- Recall date
- March 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)