Abbott Laboratories: Medical Device Recall in 2022 - (Recall #: Z-1455-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

Product Classification:

Class II

Date Initiated: June 9, 2022

Date Posted: August 3, 2022

Recall Number: Z-1455-2022

Event ID: 90499

Reason for Recall:

There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

Status: Ongoing

Product Quantity: 7,391 units

Code Information:

UDI/DI: 00380740135591/ Lots: 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, 61658UQ01

Distribution Pattern:

US: AK AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NJ NV NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: ALBANIA ALGERIA ANDORRA ANGOLA ARGENTINA ARMENIA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BANGLADESH BELARUS BELGIUM BERMUDA BOSNIA AND HERZEGOVI BRAZIL BRUNEI BULGARIA BURKINA FASO CANADA CHILE CHINA COLOMBIA COSTA RICA Country CROATIA CYPRUS CZECH REPUBLIC ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FAROE ISLANDS FINLAND FRANCE GABON GERMANY GREECE GUATEMALA HONG KONG HUNGARY INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAMAICA JORDAN KAZAKHSTAN KENYA KUWAIT KYRGYZSTAN LEBANON LIBYA LITHUANIA MACEDONIA MALAYSIA MALDIVES MALI MEXICO MOLDOVA MOROCCO MOZAMBIQUE NAMIBIA NETHERLANDS NIGERIA NORWAY OMAN PAKISTAN PALESTINIAN TERRITOR PANAMA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL QATAR REPUBLIC OF KOSOVO REPUBLIC OF YEMEN ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SPAIN ST. LUCIA ST. VINCENT SWEDEN SWITZERLAND TANZANIA THAILAND THE GAMBIA TRINIDAD & TOBAGO TUNISIA TURKEY TURKS & CAICOS UAE UGANDA UNITED KINGDOM URUGUAY UZBEKISTAN VIETNAM ZIMBABWE

Voluntary or Mandated:

Voluntary: Firm initiated