ACL TOP Family 50 Series recall
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing…
Why was ACL TOP Family 50 Series recalled?
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing…
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 2,068 kits US: 6,270 units OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.
- Recall date
- September 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)