ACL TOP 750 LAS 00000280035Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08426950784050), received between Oct 3, 2022 and Nov 22, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Data Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Use of Device Problem; Use of Device Problem

  A COMPLAINT WAS REPORTED ON (B)(6)2024 REGARDING ACL TOP 750 LAS SN (B)(6), INDICATING THAT THE PROBE SCRAPED ACROSS FINGERTIPS OF THE TECHNOLOGIST WHEN SHE REACHED TOO FAR IN PAST CONVEYOR BELT TRYING TO ALIGN CUVETTES ON ACL TOP 750 LAS SN (B)(6). IT WAS NOTED THAT THE GLOVE THE TECHNICIAN WAS WEARING WAS STILL INTACT BUT A SMALL SCRATCH WAS SEEN ON FINGERTIP. TECHNICIAN WENT TO EMERGENCY ROOM AND FOLLOWED UP WITH OCCUPATIONAL HEALTH. OCCUPATIONAL HEALTH PLACED HER ON A PEP FOR POTENTIAL EXPOSURE FOR 28 DAYS AND SCHEDULED FOLLOW-UP. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE SCRAPE.

  Patient problems: Abrasion

  MAUDE report 20762833 ↗
• InjuryNov 21, 2024Use of Device Problem; Use of Device Problem

  A COMPLAINT FROM JAPAN WAS REPORTED ON 11/11/2024 REGARDING ASSY, SYSTEM, ACL TOP 750 LAS (PART NUMBER 00000280035) THAT MENTIONS THAT A STAFF MEMBER WAS INJURED BY A PART IN THE BACK OF THE CUVETTE WASTE BOX FROM INSTRUMENT ACL TOP 750 LAS SN (B)(6). WHEN SHE REMOVED THE BOX FROM THE INSTRUMENT AND PUT HER HAND ON IT, SHE CUT HER HAND ON THE METAL PART OF THE PLATE SPRING ON THE BACK OF THE BOX. IT WAS NOTED THAT BECAUSE OF THE RISK OF INFECTION, A STICKING PLASTERS WAS PUT ON WOUND SITE AND INJURED STAFF MEMBER WILL BE ALSO TAKING POST EXPOSURE DRUGS TO PREVENT AGAINST HIV VIRUS FOR 1 MONTH.

  Patient problems: Abrasion

  MAUDE report 20745498 ↗
• InjuryOct 11, 2022Data Problem; Data Problem

  IT WAS REPORTED THAT THE ACL TOP 750 LAS ANALYZER INCORRECTLY READ A PATIENT SAMPLE BAR CODE ON (B)(6) 2022. THE OPERATOR WAS REVIEWING OUTSTANDING REQUESTS ON THE LIS AND NO RESULTS WERE PRESENT FOR SAMPLE NUMBER (B)(6) ON LIS. THE OPERATOR REMOVED THE PHYSICAL TUBE AND VIEWED THE BARCODE LABEL, THE SAMPLE THAT HAD READ AS (B)(6) ON THE ACL TOP SAMPLE LIST WAS ACTUALLY EYE-READABLE AS (B)(6). ON CHECKING THE GENERAL LOG FOR THE PERIOD ON TIME INVOLVED, THERE WAS NO NON-IDENTIFIED SAMPLE ERROR RECORDED DURING THIS TIME. SAMPLE ID (B)(6) HAD NO DEMOGRAPHIC UPLOADED TO ACL TOP FROM HEMOHUB. THE OPERATOR REPRINTED THE BAR CODES FOR EACH SAMPLE NUMBER AND LOADED ON THE ACL TOP. BOTH SAMPLE BARCODES READ CORRECTLY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578943 ↗
• InjuryOct 3, 2022Data Problem; Data Problem

  IT WAS REPORTED THAT THE ACL TOP 750 LAS ANALYZER INCORRECTLY READ A PATIENT SAMPLE BAR CODE ON (B)(6) 2022, AND POPULATED THE TEST RESULTS TO THE INCORRECT PATIENT IN THE HOSPITAL INFORMATION SYSTEM (HIS). THE ERROR WAS NOTICED BEFORE CLINICIANS HAD SEEN/ACTED UPON THE INCORRECT RESULTS. THE LABELS IN QUESTION WERE REPRINTED ON (B)(6) 2022 AND WERE READ CORRECTLY BY THE ACL TOP 750 LAS ANALYZER. THERE WAS NO PATIENT IMPACT AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527228 ↗