The Recall Desk
HighFDA (Devices)·Z-2578-2023·Announced 2023-09-20

Medical Device Recall: ACL TOP Coagulation Analyzers for Sample Misidentification

Instrumentation Laboratory is recalling ACL TOP coagulation analyzers due to potential sample misidentification that could result in incorrect test results and alter patient management decisions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an in vitro diagnostic device presenting a risk-of-harm hazard (sample misidentification leading to incorrect test results and altered patient management). No illnesses or injuries have been reported. Per the rubric, this meets the High (3) criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Instrumentation Laboratory is recalling certain models of the ACL TOP Family 50 Series in vitro diagnostic devices used for coagulation and hemostasis testing. The recalled models include the ACL TOP 550 CTS, ACL TOP 750 CTS, ACL TOP 350 CTS, ACL TOP 750, ACL TOP 750 LAS, and ACL TOP 970 CL, affecting approximately 2,068 kits distributed in the US and 6,270 units distributed outside the US.

The recall was initiated because sample misidentification could occur under specific conditions. When a sample is misidentified, the device may produce an incorrectly assigned test result, which could lead to altered patient management based on inaccurate coagulation or hemostasis findings.

The affected devices are distributed in the United States and internationally to Canada, Finland, Ireland, Lithuania, Malta, Qatar, and Sweden. Healthcare facilities and clinical laboratories using these devices should verify whether they possess affected units by model number and serial number range as detailed in the FDA recall notice.

Persons using these devices should contact Instrumentation Laboratory with questions about affected units. The FDA has provided updated information including affected serial number ranges for each model to assist in identification.

The recalled product

Product
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 N
Manufacturer
Instrumentation Laboratory
Category
Medical Device — In vitro diagnostic / Coagulation analyzer
Hazard
  • sample-misidentification
  • diagnostic-error
  • incorrect-test-result

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 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
  • (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
  • ACL TOP 550 CTS 21112046 23072623
  • ACL TOP 750 22010516 23060671
  • ACL TOP 750 CTS 21110860 23071015
  • ACL TOP 750 LAS 21120879 23071077

Distribution

Distributed nationwide across the United States.

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