CLASS II ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report
ACL TOP Family 50 Series recalled by Instrumentation Laboratory
Instrumentation Laboratory is recalling ACL TOP Family 50 Series, distributed nationwide in the US. The recall was initiated on 13 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2578-2023
- FDA event ID
- 92831
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2023
- FDA classified
- 12 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Jul 2023 | Recall initiated by company | |
| 12 Sep 2023 | Classified by FDA | +61 days |
| 20 Sep 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.
Questions about this recall
Why was it recalled?
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Which lots are affected?
Model Names UDI (1)ACL TOP 550 CTS 08426950729242; (2)ACL TOP 750 CTS 08426950784067; (3)ACL TOP 350 CTS 08426950784081; (4) ACL TOP 750 08426950784074; (5) ACL TOP 750 LAS 08426950784050 (6) ACL TOP 970 CL 08430793045476 Software: 1)ACL TOP 550 CTS v6.3.0 or later; (2)ACL TOP 750 CTS v6.3.0 or later; (3)ACL TOP 350 CTS v6.3.0 or later; (4) ACL TOP 750 v6.3.0 or later; (5) ACL TOP 750 LAS v6.3.0 or later; (6) ACL TOP 970 CL Version 1.1.0 (OUS). UPDATE: 10/16/23 Affected Serial Number Range Start SN End SN ACL TOP 350 CTS 21113058 23074369; ACL TOP 550 CTS 21112046 23072623; ACL TOP 750 22010516 23060671; ACL TOP 750 CTS 21110860 23071015; ACL TOP 750 LAS 21120879 23071077
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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