Z-2551-2019Class II

MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the...

Name: Z-2551-2019 MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the...
Creator: Sentinel CH SpA
Published: 2019-06-28
License: https://open.fda.gov/license/

Sentinel CH SpA / initiated 2019-06-28 / Terminated

FDA source

Sentinel CH SpA began a recall of MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List... on 2019-06-28. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2551-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-28
Posted: 2019-09-20
Terminated: 2020-07-24
Recalling firm: Sentinel CH SpA
Product: 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
Product code: NDW Assay, Porphyrin, Spectrophotometry, Lithium
Reason for recall: 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
FDA 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 in commerce: 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 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
Product codes and lots: Lot Number/UDI: 71175Y600 (01)003807400177712(17)191031(10)71175Y600; 80362Y600 (01)003807400177712(17)200131(10)80362Y600; 80201Y600 (01)003807400177712(17)200131(10)80201Y600; 80533Y600 (01)003807400177712(17)200630(10)80533Y600; 80463Y600 (01)003807400177712(17)200630(10)80463Y600; 80424Y600 (01)003807400177712(17)200630(10)80424Y600; 80605Y600 (01)003807400177712(17)200930(10)80605Y600; 90208Y600 (01)003807400177712(17)210131(10)90208Y600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2551-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2551-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-20
Z-2552-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-20

Product code NDW

K070987Class IISentinel Lithium AssaySENTINEL CH. SpA / cleared 2007-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)