Z-1456-2022Class II

REF: 08P4377, 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

Name: Z-1456-2022 REF: 08P4377, 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
Creator: Abbott Laboratories
Published: 2022-06-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-06-09 / Open, Classified

FDA source

Abbott Laboratories began a recall of REF: 08P4377, 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 on 2022-06-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1456-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-09
Posted: 2022-07-22
Recalling firm: Abbott Medical
Product: REF: 08P4377, 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 code: PDJ Hemoglobin A1c Test System
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.
FDA root cause: Under Investigation by firm
Action: On June 9, 2022, Abbott issued a "Urgent Medical Device Correction" to affected consignees via FedEx. 1. Immediately install the updated assay file versions listed below (as applicable for your laboratory), and manually configure the Low-Linearity value. The assay files can be obtained from www.corelaboratory.abbott 2. For the whole blood application, manually configure the THbWB Low-Linearity to 53.8278. For the hemolysate application, manually configure the THbH Low-Linearity to 1250. For detailed information on editing assay parameters, refer to Changing assay configuration settings, Change a linearity range in the ARCHITECT System Operations Manual, Section 2. 3. Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results. 4. Complete and return the Customer Reply Form. 5. Please retain this letter for your laboratory records. 6. 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.
Quantity in commerce: 64 units
Distribution: 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
Product codes and lots: UDI/DI: 00380740174989/ Lots: 59801UQ04 and 60763UQ09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1456-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1454-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-22
Z-1455-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-22
Z-1456-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-22

Product code PDJ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)