Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.
Recall record
- Recalling firm
- Instrumentation Laboratory
- Product type
- Devices
- Recall number
- Z-2578-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Bedford, MA
- Recall initiated
- 2023-07-13
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2578-2023 · Source: openFDA enforcement.