Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 3, 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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abbott Laboratories recalled REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL… - a moderate-severity action.
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL… was recalled by Abbott Laboratories in August 3, 2022. Reason: There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using th…. Check the official notice for the remedy. Verify recall #Z-1456-2022 with the FDA Devices before acting.
The recall
Abbott Laboratories issued this moderate-severity FDA Devices recall-There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using th….
- Moderate
- severity level
- 64 units
- affected scope
- Class II
- classification
- August 3, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1456-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1456-2022) was formally reported on August 3, 2022, with the manufacturer initiating the action on June 9, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Laboratories is listed as the recalling firm, operating out of Irving, TX. Federal records list the affected scope as 64 units.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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 BA…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
64 units
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1456-2022 |
| Date reported | August 3, 2022 |
| Date initiated | June 9, 2022 |
| Recalling firm | Abbott Laboratories |
| Firm location | Irving, TX |
| Affected scope | 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 BEL… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1456-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Abbott Laboratories. Units affected: 64 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2022. Severity: Moderate. Recall number: Z-1456-2022.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1456-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 3, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.