Sentinel CH SpA Via Robert Koch Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results

Recommended Action

Per FDA guidance

Sentinel issued Urgent Field Safety Notice letter on 6/28/19 via email to the distributor. The Distributor Abbott notified customers by letter Urgent Field Safety Notice Product Correction dated July 11, 2019 advising of the problem, health risk and action to take: If the LDH reagent is installed on your instrument, please follow the instructions 1. Update the Lithium (LN 8L25-30) assay parameters to add the new SmartWash. For additional information, see the ARCHITECT System Operations Manual, Section 2, Configure the SmartWash settings (c System. Install the Alinit y c Lithium assay file version 6 to implement the new LDH SmartWash. Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service