Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 20, 2023
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number:
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Instrumentation Laboratory recalled ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemo… - a moderate-severity action.
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemo… was recalled by Instrumentation Laboratory in September 20, 2023. Reason: Sample misidentification could occur under specific conditions and patient management altered based on an i…. Check the official notice for the remedy. Verify recall #Z-2578-2023 with the FDA Devices before acting.
The recall
Instrumentation Laboratory issued this moderate-severity FDA Devices recall-Sample misidentification could occur under specific conditions and patient management altered based on an i….
- Moderate
- severity level
- Class II
- classification
- September 20, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2578-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2578-2023) was formally reported on September 20, 2023, with the manufacturer initiating the action on July 13, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Instrumentation Laboratory is listed as the recalling firm, operating out of Bedford, MA. Federal records list the affected scope as 2,068 kits US: 6,270 units OUS.
The documented reason for this recall is: Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.. 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
2,068 kits US: 6,270 units OUS
Related Recalls
6
3 from same agency
Product description
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097
Reason for recall
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2578-2023 |
| Date reported | September 20, 2023 |
| Date initiated | July 13, 2023 |
| Recalling firm | Instrumentation Laboratory |
| Firm location | Bedford, MA |
| Affected scope | 2,068 kits US: 6,270 units OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden. |
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-2578-2023) 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? ▼
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097. Recalled by Instrumentation Laboratory. Units affected: 2,068 kits US: 6,270 units OUS.
Why was this product recalled? ▼
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2023. Severity: Moderate. Recall number: Z-2578-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2578-2023) 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 September 20, 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.