Instrumentation Laboratory recalls ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL analyzers due to potential elevated results for heparin, apixaban, or rivaroxaban when used with specific reagents. Affected units have serial numbers listed in the recall notice.
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
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Contact the company
📍Recalling firmInstrumentation Laboratory180 Hartwell Rd · Bedford, MA 01730-2443
✎ GovInfoNow plain-language explainer
Instrumentation Laboratory is recalling several blood analyzer models because using them with certain reagents may cause inaccurate test results for specific medications. This could lead to incorrect medical decisions if the results are not properly interpreted. Read more at govinfonow.com/recall/61079-instrumentation-laboratory-acl-top-300-cts-350-cts-500-cts.
“Instrumentation Laboratory ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Potential.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61079-instrumentation-laboratory-acl-top-300-cts-350-cts-500-cts. Based on FDA recall #Z-1014-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1014-2022%22&limit=1).
The FDA announced on Feb. 22, 2022, that Instrumentation Laboratory is recalling ACL TOP series coagulation analyzers due to a potential carryover issue causing elevated test results for heparin and other drugs. The agency issued updated user instructions on July 14, 2022, to address the hazard.
How to tell if you have it
ACL TOP 300 CTS (Part Number 00000280060)
ACL TOP 300 CTS Refurbished (Part Number 00000280060R)
ACL TOP 350 CTS (Part Number 00000280065)
ACL TOP 500 CTS (Part Number 00000280040)
ACL TOP 500 CTS Refurbished (Part Number 00000280040R)
ACL TOP 550 CTS (Part Number 00000280045)
ACL TOP 970 CL (Part Number 00000280097)
The hazard
The potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine). This hazard is specific to instrument models that utilize a single reagent probe.
Context
GovInfoNow's records show Instrumentation Laboratory has 13 other recalls on record since Aug. 25, 2021. Recent brand recalls include the GEM Premier 5000 PAK lysing bag solution risk (May 21, 2026), the GEM Premier 5000 wrong patient ID assignment risk (May 8, 2026), and GEM PAK warm-up errors (Jan. 20, 2026). Other recent recalls of similar products include the Siemens Atellica CH A1c_E Hemoglobin Test giving low results (Feb. 23, 2026), DxC 500i Clinical Analyzer modules showing incorrect test results due to a software issue (Sept. 2, 2026), and Accriva Diagnostics recalling directCHECK ACT-LR blood control with incorrect labeling (April 30, 2026).
How to tell if you have this one
Check the serial number on your analyzer. Affected models include ACL TOP 300 CTS, 350 CTS, 500 CTS, 550 CTS, and 970 CL with specific serial numbers listed in the recall notice.
Brand
Instrumentation Laboratory
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for the serial number on your analyzer to determine if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, El Salvador, France, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1014-2022 (February 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1014-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.