Recall StatusTerminated
Date Initiated2020-06-19
Date Terminated2024-04-10
Product Quantity3166
Reason for Recall
Quality Control results were not properly evaluated for QC failures.
Firm Action
On June 19, 2020, Abbott issued Product Correction letters to all installed Alinity ciseries instrument customers:
customers were asked to do the following action:
1. Your Abbott representative will schedule a mandatory upgrade of your Alinity ciseries to software version 3.2.0. Until software version 3.2.0 is installed on your Alinity ciseries, Abbott recommends the following workarounds for issues 1 and 2:
2. In order to restore the QC analysis function for all assay files that have been previously updated and for all future assay file revisions until software 3.2.0 is installed on your system, it will be necessary to remove and then readd the assay to all control configurations containing the assay.
3. See Appendix A for instructions to remove and readd an assay from a control that contains more than one assay.
4. See Appendix B for instructions to remove and readd an assay from a control that contains only one assay.
5. These procedures will delete historical QC data from the Quality Control Summary screen and LeveyJennings (Graph) screen. You may choose to print the QC Levey Jennings Report, the QC Summary Report and to archive control results before performing this option. QC results will remain on the Control tab of the Results screen.Assay calibration data, calibrator configuration data and assay parameter configuration data are retained.
6. Please complete the included Abbott Customer Reply Form.
7. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.
8.Please retain this letter for your laboratory records.
For any questions, U.S. Customers can contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., were asked to contact local area Customer Service
Root Cause
Under Investigation by firm
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.