PlainRecalls
FDA Devices Moderate Class II Ongoing

Alinity m System, Part Number: 08N53-002

Reported: May 1, 2024 Initiated: March 20, 2024 #Z-1602-2024

Product Description

Alinity m System, Part Number: 08N53-002

Reason for Recall

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.

Details

Recalling Firm
Abbott Molecular, Inc.
Units Affected
1,012 units
Distribution
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.
Location
Des Plaines, IL

Frequently Asked Questions

What product was recalled? ▼
Alinity m System, Part Number: 08N53-002. Recalled by Abbott Molecular, Inc.. Units affected: 1,012 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1602-2024.

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