ACL TOP 750 CTS 00000280055Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08426950784067), received between Dec 30, 2020 and May 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 13, 2023Class IIOpen, Classified

   Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

   Z-2578-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Device Handling Problem; Device Handling Problem

  AN UNEXPECTED BEHAVIOUR HAS OCCURRED IN AN ACL TOP SW 6.4.0 SN: (B)(6) , WHEN A RACK ID (B)(6) WAS INSERTED IN POSITION S3 THE LAST TUBE WAS NOT RECOGNIZED AND THE POSITION WAS SHOWN IN GREY. BUT THE ID INFORMATION WAS THERE. AN EMERGENCY STOP HAD TO BE DONE IN ORDER TO TAKE OUT THE RACK. STEPS SEEN IN THE COMPLAINT: USER SWITCHES THE LAST SAMPLE VIAL ((B)(6) ) FOR A DIFFERENT ONE ((B)(6) ) THAT ONLY HAS 3 HOST QUERIED TESTS, AND REINSERTS RACK IN SAME SLOT. MINUTES LATER, THE USER INSERTS SAMPLE (B)(6) IN A DIFFERENT SAMPLE RACK. DURING THE RUN SESSION, THE USER ONLY SEES ONE TEST RUNNING FOR SAMPLE (B)(6) , THE RUN SESSION NEVER FINISHES AND FINALLY HAS TO ESTOP THE INSTRUMENT. IT WAS NOT NOTICED BY THE COMPLAINT SUBMITTER, HOWEVER IN THE TRACES WE HAVE FOUND THAT 11 TESTS OF SAMPLE (B)(6) WERE REALLY EXECUTED (ASPIRATED) FROM SAMPLE (B)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963103 ↗
• InjuryMay 3, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A CUSTOMER WAS PERFORMING THE MANUAL NEEDLE CLEANING PROCEDURE OF THE PIERCER PROBE ASSEMBLY ON THE ACL TOP 750 CTS ANALYZER AND PUNCTURED HIS FINGER. FOLLOWING HOSPITAL PROTOCOL, TREATMENT WAS PROVIDED IN THE EMERGENCY ROOM OF THE HOSPITAL. MEDICAMENT AND BANDAGE WERE PROVIDED TO THE INJURED FINGER. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE PUNCTURE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11759548 ↗
• InjuryDec 30, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE COMPLAINT STATED THAT THERE WAS A MALFUNCTION OF THE BARCODE READER ON THE ACL TOP 750 CTS INSTRUMENT. THE INSTRUMENT BARCODE READER MISREAD A PATIENT SAMPLE IDENTIFICATION NUMBER AND THE SAMPLE RESULTS WERE ASSIGNED TO ANOTHER PATIENT. THE RESULTS WERE NOT TRANSMITTED TO THE LABORATORY INFORMATION SYSTEM (LIS) AND THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11097915 ↗