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U.S. Department of Health and Human Services

Class 2 Device Recall Alinity ci series

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 Class 2 Device Recall Alinity ci seriessee related information
Date Initiated by FirmJune 19, 2020
Create DateJuly 24, 2020
Recall Status1 Terminated 3 on April 10, 2024
Recall NumberZ-2701-2020
Recall Event ID 85914
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductAlinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Code Information All serial numbers of System Control Module
FEI Number 3002809144
Recalling Firm/
Manufacturer		 Abbott Gmbh & Co. KG
Max-Planck-Ring 2
65205
Wiesbaden Germany
For Additional Information ContactDana Schmidt
224-667-8598
Manufacturer Reason
for Recall		Quality Control results were not properly evaluated for QC failures.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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
Quantity in Commerce3166
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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