Recall Z-2551-2019 ยท NDW Assay, Porphyrin, Spectrophotometry, Lithium
Sentinel CH SpA
MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
| Date | Jun 28, 2019 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 ver |
| Quantity | 15919 kits |
| Distribution | Nationwide Foreign: ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BANGLADESH BELARUS BELGIUM BOSNIA AND HERZEGOVI BRAZIL BRUNEI CANADA CHILE COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK FAROE ISLANDS FINLAND FRANCE GERMANY GREECE GREENLAND HONG KONG IRELAND ISRAEL ITALY JORDAN KUWAIT LEBANON LUXEMBOU |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070987 | SENTINEL LITHIUM ASSAY SENTINEL CH. SpA, Aug 2, 2007 |