Z-2701-2020 Class II Terminated

Recalled by Abbott Gmbh & Co. KG — Wiesbaden, N/A

FDA device recall Z-2701-2020 was initiated by Abbott Gmbh & Co. KG on June 19, 2020 and is designated Class II. Reason for recall: Quality Control results were not properly evaluated for QC failures. The recall status is terminated (terminated April 10, 2024). Affected quantity: 3166.

Recall Details

Product Type
Devices
Report Date
August 5, 2020
Initiation Date
June 19, 2020
Termination Date
April 10, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3166

Product Description

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 Pattern

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.

Code Information

All serial numbers of System Control Module