Sekisui Diagnostics P.E.I. Inc.: Medical Device Recall in 2017 - (Recall #: Z-1078-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 29, 2016

Date Posted: February 1, 2017

Recall Number: Z-1078-2017

Event ID: 75818

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.

Status: Terminated

Product Quantity: 774 Liters bulk and 565 kits

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

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

Voluntary or Mandated:

Voluntary: Firm initiated