Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 19, 2025
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abbott Laboratories recalled Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number:… - a moderate-severity action.
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number:… was recalled by Abbott Laboratories in November 19, 2025. Reason: Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when sa…. Check the official notice for the remedy. Verify recall #Z-0489-2026 with the FDA Devices before acting.
The recall
Abbott Laboratories issued this moderate-severity FDA Devices recall-Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when sa….
- Moderate
- severity level
- 833 units
- affected scope
- Class II
- classification
- November 19, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0489-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0489-2026) was formally reported on November 19, 2025, with the manufacturer initiating the action on September 18, 2025. 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 Santa Clara, CA. Federal records list the affected scope as 833.
The documented reason for this recall is: Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, C…. 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
833
Related Recalls
6
3 from same agency
Product description
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
Reason for recall
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0489-2026 |
| Date reported | November 19, 2025 |
| Date initiated | September 18, 2025 |
| Recalling firm | Abbott Laboratories |
| Firm location | Santa Clara, CA |
| Affected scope | 833 |
| Distribution | Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLAND… |
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-0489-2026) 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? ▼
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No. Recalled by Abbott Laboratories. Units affected: 833.
Why was this product recalled? ▼
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2025. Severity: Moderate. Recall number: Z-0489-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE,UNITED KINGDOM, URUGUAY, and VIETNAM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0489-2026) 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.
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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 November 19, 2025. 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.