Sekisui Recalls 1,600 Acetaminophen Assay Kits Due to Reagent Discoloration
Sekisui Diagnostics is recalling 1,600 MULTIGENT Acetaminophen assay kits distributed in Illinois because discoloration of the enzyme reagent causes erratic test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a quality defect (discoloration) leading to inaccurate test results, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Sekisui Diagnostics LLC is recalling 1,600 kits of the MULTIGENT Acetaminophen assay (Catalog No. 2K99-20) intended for use with Architect/Aeroset systems. The affected product is Lot 41928UQ11, which has an expiration date of January 31, 2013. The recall is limited to distribution in Illinois.
The recall was initiated because the acetaminophen enzyme reagent (R1) in the kits has undergone discoloration. This discoloration generates a high calibration factor and results in erratic control recovery, which compromises the reliability of the quantitative determination of acetaminophen in human serum or plasma.
Healthcare facilities and laboratories that have received this specific lot of the assay should stop using the product and contact the manufacturer for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- 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.
- Manufacturer
- Sekisui Diagnostics Llc
- Affected units
- 1,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 41928UQ11 {exp 2013-01 -31 )
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Sekisui Diagnostics Llc
See all →- HighOSOM C. Difficile Toxin A/B Test Kit Recalled for False Negative Risk
FDA (Devices) · 2013-10-23
- ModerateSekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values
FDA (Devices) · 2012-12-12
- ModerateSekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values
FDA (Devices) · 2012-09-26
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06