FDA Medical Device Recalls (openFDA)
Sentinel CH SpA: 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 number
- Z-2552-2019
- Recalling firm
- Sentinel CH SpA
- Product
- 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
- Status
- Terminated
- Initiated
- 2019-06-28
- Posted
- not on file
- Terminated
- 2020-07-24
- 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 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
- Quantity
- 1217 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 LUXEMBOURG MALAYSIA MALDIVES MEXICO MOROCCO NETHERLANDS NEW ZEALAND NIGERIA NORWAY OMAN PAKISTAN PANAMA PARAGUAY PHILIPPINES POLAND PORTUGAL PUERTO RICO ROMANIA RWANDA SAUDI ARABIA SLOVAKIA SOUTH AFRICA SPAIN ST. VINCENT SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UAE UNITED KINGDOM URUGUAY
- Lot, serial or model codes
- Lot Number/UDI: 80553Y600/ (01)00380740136277 (17)190731(10)80553Y600; 80444Y600/ (01)00380740136277 (17)190731(10)80444Y600; 80625Y600/ (01)00380740136277 (17)191130(10)80625Y600; 90224Y600/ (01)0038074013627 (17)200229(10)90224Y600
- 510(k) numbers
- ["K070987"]
- PMA numbers
- not on file
- Product code
- NDW
- Firm FEI
- 3000303338
- Firm city
- Milan
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28