Reported Mar 23, 2016 · Terminated
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml,…
Sekisui Diagnostics P.E.I. Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sekisui Diagnostics P.E.I. Inc. · 70 Watts Ave · Charlottetown · N/A
Is this the product you have?
- Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay
- In-vitro Diagnostic Catalog Number506-10:
- R11 x 10ml
- R22
- x 10ml Catalog Number506-30:
- R13 x 10ml
- R26 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity
- Lot codes and dates
- Catalog Number506-10 Lot Codes
476774769447649476504766247663482534838548386
- Catalog Number506-30
- Lot Codes47695 48294
- Catalog Number506-10 Lot Codes
- Amount recalled
- 14,407 kits.
Where it was sold
Why it was recalled
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
This product could cause temporary or reversible health problems — stop using it.
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