# FDA recall Z-2552-2019

> **Sentinel CH SpA** · Class II · device recall initiated 2019-06-28.

## 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

## 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

## 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

## Key facts

- **Recall number:** Z-2552-2019
- **Recalling firm:** Sentinel CH SpA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-28
- **Report date:** 2019-10-02
- **Termination date:** 2020-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milan, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2552-2019

## Citation

> AI Analytics. FDA recall Z-2552-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2552-2019. Source: US FDA. Licensed CC0.

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