FDA recall Z-2701-2020

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

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

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