Reported Jul 4, 2012 · Terminated
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative…
Sekisui Diagnostics LLC
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 Llc · 31 New York Ave · Framingham, MA · 01701-8860
Is this the product you have?
- MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
- Lot codes and dates
- Lot 41928UQ11 {exp 2013-01 -31 )
- Amount recalled
- 1600 kits
Where it was sold
Why it was recalled
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
This product could cause temporary or reversible health problems — stop using it.
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