Z-1602-2024 Class II Ongoing
FDA device recall Z-1602-2024 was initiated by Abbott Molecular, Inc. on March 20, 2024 and is designated Class II. 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:… The recall status is ongoing. Affected quantity: 1,012 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- March 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,012 units
Product Description
Reason for Recall
Distribution Pattern
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.