Instrumentation Laboratory: Medical Device Recall in 2023 - (Recall #: Z-2578-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 13, 2023

Date Posted: September 20, 2023

Recall Number: Z-2578-2023

Event ID: 92831

Reason for Recall:

Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

Status: Ongoing

Product Quantity: 2,068 kits US: 6,270 units OUS

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

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated