ACL TOP 500 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 500 CTS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 1
We found 2 models of ACL TOP 500 CTS by Instrumentation Laboratory Company in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2017 and Oct 13, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (2 reports).
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
Reports received per month, all models
ACL TOP 500 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 500 CTS problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Use of Device Problem2
- Insufficient Device Problem Information1
Patient problems
- Therapeutic Response, Increased6
- Abrasion1
- Needle Stick/Puncture1
ACL TOP 500 CTS models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACL TOP 500 CTS 00000280040INSTRUMENT, COAGULATION, AUTOMATED1 recall8 reports
- ACL TOP 500 CTS 00000280040RINSTRUMENT, COAGULATION, AUTOMATED1 recall0 reports
Recent ACL TOP 500 CTS adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 13, 2023Use of Device Problem; Use of Device Problem
CUSTOMER INJURED FINGER WHILE REMOVING SAMPLE TUBE FROM CTS SAMPLE PROBE WHILE TROUBLESHOOTING. CUSTOMER WAS WEARING GLOVES AT THE TIME. CUSTOMER WENT TO OCCUPATIONAL HEALTH TO BE EVALUATED.
Patient problems: Abrasion
MAUDE report 17934001 ↗InjuryMay 17, 2023Use of Device Problem; Use of Device Problem
THE CUSTOMER WAS INJURED DURING MAINTENANCE PROCEDURE "CLEAN DEEP WASH AND CLEAN CUP AREA". THE CUSTOMER CLEANED THE SAMPLE CUP AREA AND AFTER THIS OPERATION TURNED UP THE FOOTER AND WAS INJURED WITH THE PIERCER. THE CUSTOMER WAS WEARING GLOVES. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE PUNCTURE.
Patient problems: Needle Stick/Puncture
MAUDE report 16948092 ↗InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS GENERATED ERRONEOUS APTT RESULTS USING HEMOSIL SYNTHASIL. FOUR PATIENTS HAD RESULTS THAT WERE CLINICALLY SIGNIFICANT AND NEEDED TO BE CORRECTED. ONE PATIENT WAS ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THE ERRONEOUS APTT RESULT. THE APTT RESULT WAS LATER CORRECTED AND THE HEPARIN DOSE WAS ADJUSTED AS APPROPRIATE. THERE WERE NO KNOWN COMPLICATIONS TO THE PATIENT FROM THE ADDITIONAL HEPARIN ADMINISTERED.
Patient problems: Therapeutic Response, Increased
MAUDE report 8956671 ↗InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS GENERATED ERRONEOUS APTT RESULTS USING HEMOSIL SYNTHASIL. FOUR PATIENTS WERE ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THE ERRONEOUS APTT RESULTS. AFTER THE ADDITIONAL DOSE OF HEPARIN, THE PATIENTS WERE MONITORED WITH NO FURTHER REPORTS OF CLINICAL IMPLICATIONS.
Patient problems: Therapeutic Response, Increased
MAUDE report 8225762 ↗InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS GENERATED AN ERRONEOUS APTT RESULT (36.9 SECONDS) USING HEMOSIL SYNTHASIL. A PATIENT WAS ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THIS ERRONEOUS APTT RESULT. SUBSEQUENTLY, ANOTHER SAMPLE WAS DRAWN FROM THE SAME PATIENT (APPROXIMATELY 3 HOURS LATER) AND IT REPORTED AN APTT RESULT OF > 200. THE HEPARIN ADMINISTRATION WAS STOPPED AND THE CUSTOMER INDICATED THAT THE PATIENT'S APTT RESULT WAS BROUGHT BACK INTO THE THERAPEUTIC RANGE. THERE WERE NO FURTHER REPORTS OF CLINICAL IMPLICATIONS FOR THE PATIENT.
Patient problems: Therapeutic Response, Increased
MAUDE report 8024101 ↗InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT RESULTS FOR 6 PATIENTS USING HEMOSIL SYNTHASIL. ALL 6 PATIENT SAMPLE RESULTS WERE RE-RUN AND CORRECTED. ONE PATIENT (CH) WAS ADMINISTERED A BOLUS OF HEPARIN. CH DEVELOPED A SUPERFICIAL RIGHT GROIN HEMATOMA. THE CUSTOMER WAS UNABLE TO DETERMINE IF THIS WAS A RESULT OF THE BOLUS OF HEPARIN.
Patient problems: Therapeutic Response, Increased
MAUDE report 7038808 ↗InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. SIX PATIENT SAMPLES GENERATED ERRONEOUS RESULTS. ONE PATIENT WAS ADMINISTERED AN UNNECESSARY BOLUS OF HEPARIN DUE TO THE APTT RESULT BEING LOWER THAN EXPECTED. ALL SIX SAMPLES WERE SUBSEQUENTLY CORRECTED AND THERE WERE NO REPORTED SERIOUS ADVERSE EVENTS.
Patient problems: Therapeutic Response, Increased
MAUDE report 6885953 ↗InjurySep 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. OF THE 41 AFFECTED PATIENT SAMPLES, FIFTEEN TO TWENTY PATIENTS WERE ADMINISTERED UNNECESSARY BOLUSES OF HEPARIN DUE TO RESULTS BEING LOWER THAN EXPECTED. ALL FORTY-ONE SAMPLES WERE SUBSEQUENTLY CORRECTED AND THERE WERE NO REPORTED SERIOUS ADVERSE EVENTS.
Patient problems: Therapeutic Response, Increased
MAUDE report 6856196 ↗
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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