Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 30, 2022
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abbott Molecular, Inc. recalled Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use - a moderate-severity action.
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use was recalled by Abbott Molecular, Inc. in November 30, 2022. Reason: Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In …. Check the official notice for the remedy. Verify recall #Z-0268-2023 with the FDA Devices before acting.
The recall
Abbott Molecular, Inc. issued this moderate-severity FDA Devices recall-Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In ….
- Moderate
- severity level
- 883 units
- affected scope
- Class II
- classification
- November 30, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0268-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0268-2023) was formally reported on November 30, 2022, with the manufacturer initiating the action on October 12, 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 883 units.
The documented reason for this recall is: Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed a… Distribution data in the federal record shows the product reached: Worldwide distribution.. 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
883 units
Related Recalls
6
3 from same agency
Product description
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Reason for recall
Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0268-2023 |
| Date reported | November 30, 2022 |
| Date initiated | October 12, 2022 |
| Recalling firm | Abbott Molecular, Inc. |
| Firm location | Des Plaines, IL |
| Affected scope | 883 units |
| Distribution | Worldwide distribution. |
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-0268-2023) 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, REF 08N53-002, For In Vitro Diagnostic Use. Recalled by Abbott Molecular, Inc.. Units affected: 883 units.
Why was this product recalled? ▼
Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2022. Severity: Moderate. Recall number: Z-0268-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0268-2023) 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 November 30, 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.