Z-2701-2020Class II

Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below

Name: Z-2701-2020 Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Creator: Abbott Gmbh & Co. KG
Published: 2020-06-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-06-19 / Terminated

FDA source

Abbott Gmbh & Co. KG began a recall of Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below on 2020-06-19. FDA classified it as Class II and gives the reason as "Quality Control results were not properly evaluated for QC failures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2701-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-19
Posted: 2020-07-24
Terminated: 2024-04-10
Recalling firm: Abbott Medical
Product: Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Quality Control results were not properly evaluated for QC failures.
FDA root cause: Under Investigation by 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
Quantity in commerce: 3166
Distribution: 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.
Product codes and lots: All serial numbers of System Control Module

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2701-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2701-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-24

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)