REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Summary
The FDA issued a Class II for REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 by Abbott Laboratories. Reason: There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c.
Details
Source
Device Recall
External ID
Z-1454-2022
Action Date
2022-08-03
Status
Ongoing
Category
device
Product Description
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Lot/Code Info: UDI/DI: 00380740102746/ Lots: 59588UQ04, 59868UQ05, 59900UQ06, 60138UQ07, 60237UQ08, 60535UQ08, 60698UQ09, 60880UQ10, 61066UQ11, 61246UQ01, 61250UQ01
Quantity Affected: 103,316
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-09
Company
Irving, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1454-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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