ACL TOP 300 CTSRecalls & reported problems across all models
Instrumentation Laboratory Company · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ACL TOP 300 CTS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of ACL TOP 300 CTS by Instrumentation Laboratory Company in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jun 11, 2020 and Jun 11, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
ACL TOP 300 CTS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 22, 2022Open, Classified
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
Z-1014-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported ACL TOP 300 CTS problems
Device problems
- Use of Device Problem1
Patient problems
- Needle Stick/Puncture1
ACL TOP 300 CTS models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACL TOP 300 CTS 00000280060INSTRUMENT, COAGULATION, AUTOMATED1 recall1 report
- ACL TOP 300 CTS 00000280060RINSTRUMENT, COAGULATION, AUTOMATED1 recall0 reports
Recent ACL TOP 300 CTS adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 11, 2020Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A CUSTOMER WAS PERFORMING REAGENT PROBE COORDINATE ADJUSTMENT ON THE ACL TOP 300 CTS ANALYZER. THE USER NOTICED THE CTS FOOT WAS DIRTY AND PRECEDED TO CLEAN THE CTS FOOT. WHILE ATTEMPTING TO CLEAN THE CTS FOOT, THE USER'S HAND WAS CUT. CUSTOMER WAS WEARING GLOVES AT TIME OF INCIDENT. SHE WENT TO EMERGENCY ROOM PER LAB POLICY.
Patient problems: Needle Stick/Puncture
MAUDE report 10145652 ↗
Other Instrumentation Laboratory Company products
All Instrumentation Laboratory Company devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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