Z-1078-2017 Class II Terminated
FDA device recall Z-1078-2017 was initiated by Sekisui Diagnostics P.E.I. Inc. on November 29, 2016 and is designated Class II. 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. The recall status is terminated (terminated July 6, 2017). Affected quantity: 774 Liters bulk and 565 kits.
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