CLASS II ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report

REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x recalled

Abbott Laboratories is recalling REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0, distributed in 38 states. The recall was initiated on 9 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI: 00380740135591/ Lots: 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, 61658UQ01

Quantity recalled7,391 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1455-2022
FDA event ID: 90499
Recalling firm: Abbott Laboratories, Irving, TX
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jun 2022
FDA classified: 22 Jul 2022
Reported: 3 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

9 Jun 2022	Recall initiated by company
22 Jul 2022	Classified by FDA	+43 days
3 Aug 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

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

Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 90499

This product is part of a recall event; the main page for the event is REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x recalled.

Reported	Class	Recall	Company	Reason	Where
3 Aug 2022	CLASS II	REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x recalled	Abbott Laboratories	Potency & Assay	38 states
3 Aug 2022	CLASS II	REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x recalled	Abbott Laboratories	Potency & Assay	38 states

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