Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sekisui Diagnostics Ammonia L3K¿ Assay Recalled by Sekisui Diagnostics P.E.I. Inc. Due to Certain lots are showing an atypical decrease in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sekisui Diagnostics P.E.I. Inc. directly.
Affected Products
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Quantity: 774 Liters bulk and 565 kits
Why Was This Recalled?
Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
Where Was This Sold?
This product was distributed to 12 states: CA, DE, FL, ID, IL, KS, MA, MI, NJ, RI, TN, TX
About Sekisui Diagnostics P.E.I. Inc.
Sekisui Diagnostics P.E.I. Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report