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ORTHO 5561701Recalls & reported problems

Ortho-Clinical Diagnostics, Inc. · ORTHO VERSEIA™ Pipetter · Class N

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750013265), received between Apr 5, 2023 and Apr 5, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Data Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Data Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 5, 2023Data Problem; Data Problem

    HOLD CC 4.5 MXP2512587; RA601553 ON (B)(6) 2023, A CUSTOMER CONTACTED ORTHOCARE TO REPORT WHAT WAS DESCRIBED AS A BARCODE MISREAD SCANNING ISSUE ON THEIR VERSEIA PIPETTOR. THE CUSTOMER STATED THAT THEIR VERSEIA PIPETTOR COMBINED TWO SAMPLE BARCODES INTO ONE WHEN BEING LOADED ONTO THE INSTRUMENT. THE CUSTOMER REPORTED THAT, ON (B)(6) 2023, THEY WERE MANUALLY SCANNING THE BARCODES ON SAMPLES LOADED TO TEST FOR GS HIV-1/2 PLUS PLATE ID ¿ AJ2017 WHEN THEY ACCIDENTALLY SCANNED TWO BARCODES NEXT TO EACH OTHER (SAMPLE ID (B)(6) AND (B)(6) RESULTING IN A NEW SAMPLE ID BEING UPLOADED AS (B)(6). TESTING WAS COMPLETED UNDER THE COMBINED SAMPLE ID. ONCE IDENTIFIED, THE CUSTOMER STATED THAT SAMPLE (B)(6) WAS ABLE TO BE REPEATED WITH NO ISSUES AS THE BARCODE WAS UNIQUE TO THE OAS AND IT WAS THE FIRST TIME IT WAS RECOGNIZED IN THE SOFTWARE. SINCE SAMPLE ID (B)(6) HAD ALREADY BEEN PROCESSED ORIGINALLY AS A SINGLE BARCODE SCAN, A DRAW SITE HAD TO BE ASSIGNED FOR REPEAT HIV TESTING TO BE ALLOWED BY THE OAS AS A UNIQUE SAMPLE ID. THE CUSTOMER STATED THAT UPON COMPLETION OF THE TESTING, THEY CHOSE TO PREVENT THE RESULTS FROM SAMPLES (B)(6) AND (B)(6) FROM BEING RELEASED TO THE LIS AND TO REPEAT THE HI

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16682406 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.