Recall Z-1078-2017
Sekisui Diagnostics P.E.I. Inc. · initiated November 29, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Codes / lots: Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515
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.
FDA-determined cause: Material/Component Contamination
Action taken
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 CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will: Indicate receipt of this Field Correction, and confirmation of notification of customers that received impacted customers; Act as confirmation of destruction of affected product in inventory; Allow for issuance of replacement product. Customers with questions were instructed to contact Technical Services at 1-800-565-0265 or email PEIDiagnosticTechnical@sekisui-dx.com.
Details
- Recall number
- Z-1078-2017
- Initiated
- November 29, 2016
- Posted by FDA
- January 23, 2017
- Terminated
- July 6, 2017
- Product code
- JIF – Enzymatic Method, Ammonia
- 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
- Recalling firm
- Sekisui Diagnostics P.E.I. Inc., Charlottetown