Home / Recalls / Sekisui Diagnostics P.E.I. Inc. / Z-1078-2017

Z-1078-2017 Class II Terminated

Recalled by Sekisui Diagnostics P.E.I. Inc. — Charlottetown, N/A

Recall Details

Product Type: Devices
Report Date: February 1, 2017
Initiation Date: November 29, 2016
Termination Date: July 6, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 774 Liters bulk and 565 kits

Product Description

Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka

Code Information

Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515