# FDA recall Z-1455-2022

> **Abbott Laboratories** · Class II · device recall initiated 2022-06-09.

## Product

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

## 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	TA

## Key facts

- **Recall number:** Z-1455-2022
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-09
- **Report date:** 2022-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1455-2022

## Citation

> AI Analytics. FDA recall Z-1455-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1455-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*