Recall Z-1078-2017 ยท JIF Enzymatic Method, Ammonia
Sekisui Diagnostics P.E.I. Inc.
Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
| Date | Jan 23, 2017 (initiated Nov 29, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | Sekisui Diagnostics sent an Important Product Correction Notification letter dated November 29, 2016, to all affected customers. Customers were asked to take the following actions: Customer Instructions: Please stop using and discard any of the Ammonia L3K reagent lots listed above in your inventory; Contact your distributor to discuss replacement product. Distributor Instructions: Please send the "IMPORTANT PRODUCT CORRECTION Customer Notification" provided to all customers that received Sekisui Diagnostics Ammonia LJK from the listed lot numbers; Complete, sign and return the attached CO |
| Quantity | 774 Liters bulk and 565 kits |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 Diagnostic Chemicals , Ltd., Mar 10, 2004 |