Sentinel CH recalls Multigent Lithium Reagent Kits (8L25-30, 08P5320) that may cause falsely elevated lithium test results due to carryover from LDH reagent. Consumers should check product labels for lot numbers.
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
Take action
Contact the company
📍Recalling firmSentinel CH SpAVia Robert Koch 2 · Milan, Italy
“Sentinel CH Multigent Lithium Reagent Kit Recall: False High Lithium Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67543-sentinel-ch-multigent-lithium-reagent-kit-recall-false-high-lithium. Based on FDA recall #Z-2551-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2551-2019%22&limit=1).
Sentinel CH SpA recalled MULTIGENT Lithium Reagent Kits on June 28, 2019, according to the FDA. The recall addresses a hazard of falsely elevated lithium patient results due to potential carryover from another reagent.
How to tell if you have it
Brand: Sentinel CH
Product: MULTIGENT Lithium Reagent Kit for ARCHITECT c Systems and Alinity c analyzer
Catalogue numbers: 8L25-30, 08P5320
Lot numbers: 71175Y600, 80362Y600, 80201Y600, 80533Y600, 80463Y600, 80424Y600, 80605Y600, 90208Y600
Units affected: 15,919 kits
The hazard
The company added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit to prevent potential carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent. This carryover may result in falsely elevated lithium patient results.
Context
GovInfoNow's records show Sentinel CH SpA has issued three other recalls since April 30, 2021. On Sept. 29, 2023, the company recalled Iron Assay Kits for potential false results due to high recovery observed at customer sites. Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026) and Magellan LeadCare II Blood Lead Test Kits (March 13, 2026).
How to tell if you have this one
Check product labels for lot numbers: 71175Y600, 80362Y600, 80201Y600, 80533Y600, 80463Y600, 80424Y600, or 80605Y600. These kits are intended for lithium testing with ARCHITECT or Alinity c analyzers.
Brand
Sentinel CH
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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
Recall number
Product, codes & lots
Quantity
Z-2551-2019
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; 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
15919 kits
Z-2552-2019
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; 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
1217 kits
Based on the official FDA remedy
What to do — step by step
Check Product Labels
Look for lot numbers 71175Y600, 80362Y600, 80201Y600, 80533Y600, 80463Y600, 80424Y600, or 80605Y600 on the reagent kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2551-2019 (June 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2551-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.