FDA-Device2024-05-01Class II

Alinity m System, Part Number: 08N53-002

Abbott Molecular, Inc.

Hazard

The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.

Sold states

Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, LATVIA, LUXEMBOURG, MALAWI, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, MOZAMBIQUE, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, POLAND, PORTUGAL, ROMANIA, RUSSIA (CIS), SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UGANDA, UNITED KINGDOM, VIETNAM, ZIMBABWE.

Affected count

1,012 units

Manufactured in

1300 E Touhy Ave, N/A, Des Plaines, IL, United States

Products

Alinity m System, Part Number: 08N53-002

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1602-2024

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