# FDA recall Z-2701-2020

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2020-06-19.

## Product

Alinity ci series System Control Module (SCM); LN 3R70-01  Alinity ci series software versions, 3.1.1 and below

## Reason for recall

Quality Control results were not properly evaluated for QC failures.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN,   JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MADAGASCAR, MALAYSIA,   MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN  PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIA, SAUDI ARABIA,   SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, UKRAINE, URUGUAY, VIETNAM.

## Key facts

- **Recall number:** Z-2701-2020
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-19
- **Report date:** 2020-08-05
- **Termination date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2701-2020

## Citation

> AI Analytics. FDA recall Z-2701-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2701-2020. Source: US FDA. Licensed CC0.

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