FDAClass IIJuly 4, 2012

MULTIGENT Acetaminophen for use with Architect/Aeroset recall

MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in…

Why was MULTIGENT Acetaminophen for use with Architect/Aeroset recalled?

Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.

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?

Lot 41928UQ11 {exp 2013-01 -31 )

Product
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in…
Recalling firm
Sekisui Diagnostics Llc
Quantity
1600 kits
Distribution
Illinois
Recall date
July 4, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls