Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 1, 2023
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may hav…
Abbott Molecular, Inc. recalled Alinity m System. The Alinity m System is designed to automate the steps for nucleic… - a moderate-severity action.
Alinity m System. The Alinity m System is designed to automate the steps for nucleic… was recalled by Abbott Molecular, Inc. in February 1, 2023. Reason: The firm identified the following three potential issues which may have impacted ADUs installed on distribute…. Check the official notice for the remedy. Verify recall #Z-1009-2023 with the FDA Devices before acting.
The recall
Abbott Molecular, Inc. issued this moderate-severity FDA Devices recall-The firm identified the following three potential issues which may have impacted ADUs installed on distribute….
- Moderate
- severity level
- 918 units
- affected scope
- Class II
- classification
- February 1, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1009-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1009-2023) was formally reported on February 1, 2023, with the manufacturer initiating the action on December 9, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Molecular, Inc. is listed as the recalling firm, operating out of Des Plaines, IL. Federal records list the affected scope as 918 units.
The documented reason for this recall is: The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration … Distribution data in the federal record shows the product reached: x. 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
918 units
Related Recalls
6
3 from same agency
Product description
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
Reason for recall
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1009-2023 |
| Date reported | February 1, 2023 |
| Date initiated | December 9, 2022 |
| Recalling firm | Abbott Molecular, Inc. |
| Firm location | Des Plaines, IL |
| Affected scope | 918 units |
| Distribution | x |
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-1009-2023) 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? ▼
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.. Recalled by Abbott Molecular, Inc.. Units affected: 918 units.
Why was this product recalled? ▼
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2023. Severity: Moderate. Recall number: Z-1009-2023.
Where was the recalled product distributed? ▼
Distribution: x.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1009-2023) 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 February 1, 2023. 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.