The Recall Desk
HighFDA (Devices)·Z-1014-2022·Announced 2022-05-04

ACL TOP Laboratory Analyzer Carryover Contamination May Affect Test Results

Instrumentation Laboratory recalls ACL TOP coagulation analyzers due to potential carryover contamination that may cause inaccurate anticoagulation test results. When specific reagents are used together, tests for heparin, apixaban, and rivaroxaban may show elevated results.

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 medical device recall involving potential test result inaccuracy. No illnesses or injuries have been reported; the hazard is theoretical—inaccurate anticoagulation monitoring results could lead to clinical harm but no such incidents are documented. Per the severity rubric, a theoretical hazard without reported incidents scores at most 3 (High).

Plain-English summary

Instrumentation Laboratory is recalling ACL TOP coagulation analyzer models 300 CTS, 350 CTS, 500 CTS, 550 CTS, and 970 CL. These laboratory instruments are used to measure blood coagulation and monitor patients taking anticoagulation medications.

The recall addresses a potential carryover contamination issue that occurs in certain single-probe instrument models. When HemosIL Liquid Anti-Xa reagent is used in the same analytical run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine) reagents, the instruments may produce elevated test results for heparin, apixaban, and rivaroxaban. Elevated results could lead to inaccurate clinical decisions regarding anticoagulation therapy.

Approximately 2,727 units have been distributed in the United States and 5,277 units internationally. Healthcare facilities using these specific instrument models with the identified reagent combinations may be affected.

Instrumentation Laboratory issued updated user instructions on July 14, 2022. Laboratories should review the updated guidance to prevent the reagent combination that causes elevated results. Facilities should verify that test results obtained during runs using all three reagents are clinically appropriate, and consider retesting of critical samples if there is concern about carryover contamination.

The recalled product

Product
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 55
Manufacturer
Instrumentation Laboratory
Category
Medical Device — Laboratory Analyzer / Coagulation Testing
Hazard
  • carryover-contamination
  • test-result-inaccuracy

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 (6)

  • "ACL TOP 300 CTS (Refurbished)" 00000280060R 08426950928027
  • ACL TOP 350 CTS 00000280065 08426950784081
  • ACL TOP 500 CTS 00000280040 08426950453499
  • "ACL TOP 500 CTS (Refurbished)" 00000280040R 08426950928003
  • ACL TOP 550 CTS 00000280045 08426950729242
  • ACL TOP 970 CL 00000280097 08430793045476.

Distribution

Distributed nationwide across the United States.

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