Home / Recalls / Abbott Laboratories / Z-0613-2024

Z-0613-2024 Class II Ongoing

Recalled by Abbott Laboratories — Irving, TX

Recall Details

Product Type
Devices
Report Date
January 3, 2024
Initiation Date
May 30, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,424

Product Description

Alinity ci-series System Control Module, REF: 03R70-01

Reason for Recall

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

Distribution Pattern

US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, BURKINA FASO, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FAROE ISLANDS, FINLAND, FRANCE, , GAZA & JERICHO,GERMANY, GREECE, GREENLAND, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LITHUANIA, MACEDONIA, MADAGASCAR, MALAYSIA, MALDIVES, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UK, UKRAINE, URUGUAY, VIETNAM, ZAMBIA

Code Information

UDI-DI: 00380740137410. Software Version 3.4.0 and lower.

Other recalls by Abbott Laboratories

  • Z-0961-2026 Class II — Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 (November 13, 2025)
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  • Z-1655-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-2681-2024 Class II — Alinity hq Analyzer, REF: 09P68-01 (June 14, 2024)
  • Z-1476-2024 Class II — ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. (February 21, 2024)
  • F-0328-2024 Class II — Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil (October 31, 2023)