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ORTHO 6842222Recalls & reported problems

Ortho-Clinical Diagnostics, Inc. · ORTHO Optix™ Reader ID-MTS Gel · Class 2

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 10758750032846), received between Jan 6, 2023 and Jan 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (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

  • Incorrect Measurement1

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.

  • MalfunctionJan 6, 2023Incorrect Measurement; Incorrect Measurement

    (B)(4). ON (B)(6) 2022, A CUSTOMER COMPLAINED TO ORTHO CARE ABOUT WHAT WAS DESCRIBED AS A DISCORDANT BLOOD GROUP RESULTS FOR DONORS SAMPLES USING THEIR ORTHO OPTIX READER MTS. COMPLAINANT/ COMPLAINT REPORTER NAME: (B)(6). LABORATORY SUPERVISOR DATE OF EVENTS: (B)(6) 2022 DONOR¿S INFORMATION: SIX DONOR UNITS THAT WERE EXPECTED TO BE O POS. THE CUSTOMER REPORTED THAT ON (B)(6) 2022 THEY HAD TESTED SIX DONOR SAMPLES FOR RETYPING IN ABO USING MTS TECHNOLOGY IN MANUAL METHOD WITH AUTOMATIC READING ON THEIR ORTHO OPTIX READER MTS AND THAT THEY HAD OBTAINED TWO UNITS CORRECTLY RETYPED, HOWEVER THE OTHER 4 UNITS WERE TYPED AS B POS. THE CUSTOMER REPEATED TESTING ON THE FOUR SAMPLES THAT TYPED AS B POS. THE CUSTOMER OBTAINED A RESULT OF O POS FOR TWO OF THE SAMPLES AND B POS FOR THE OTHER TWO. THE CUSTOMER ONCE AGAIN REPEATED TESTING ON THE TWO SAMPLES THAT REPEATED AS B POS AND THIS TIME OBTAINED THE CORRECT RESULT OF O POS. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT NO PATIENT/DONOR HAD BEEN HARMED AS A RESULT OF THE REPORTED EVENTS. INVESTIGATION DETAILS: THE CUSTOMER REPORTED THAT THEY HAD PROCESSED QC SAMPLES THE DAY OF THE EVENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16112543 ↗

Other SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY devices

All SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY devices →

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