VITROS 6900053Recalls & reported problems
Ortho Clinical Diagnostics · VITROS Immunodiagnostic Products Intact PTH II Calibrators · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10758750032716), received between Jun 9, 2026 and Aug 3, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- High Test Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117269 ↗MalfunctionJun 9, 2026High Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS IPTH2 RESULTS OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD LOT 88750 QUALITY CONTROLS AND TWO DIFFERENT PATIENT CORRELATION SAMPLES USING VITROS IMMUNODIAGNOSTICS PRODUCTS IPTH2 CALIBRATORS, LOT 0330 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD L1 VITROS IPTH2 RESULTS OF 41.5, 40.4, 39.8 AND 41.1 NG/ML VS. THE EXPECTED VITROS IPTH2 BASELINE MEAN RESULT OF 30.29 NG/ML. BIORAD L2 VITROS IPTH2 RESULTS OF 636.4, 633.9, 643.3 AND 648.7 NG/ML VS. THE EXPECTED VITROS IPTH2 BASELINE MEAN RESULT OF 461.89 NG/ML PATIENT CORRELATION SAMPLE 1 VITROS IPTH2 RESULT OF 100.7 NG/ML VS. THE EXPECTED VITROS IPTH2 RESULT OF 74.2 NG/ML. PATIENT CORRELATION SAMPLE 2 VITROS IPTH2 RESULT OF 153.5 NG/ML VS. THE EXPECTED VITROS IPTH2 RESULT OF 113.5 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM CORRELATION SAMPLES THAT WERE NOT REPORTED OUTSIDE OF THE LABORATORY OR FROM NON-PATIENT QUALITY CONTROL SAMPLES. THERE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443134 ↗
Other Calibrator, secondary devices
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
- ARCHITECT 8K28-02Abbott Laboratories · CALIBRATOR, SECONDARY1 recall115 reports
- VITROS 8231474Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary3 recalls0 reports
- BioPlex 2200 12000651Bio-Rad Laboratories, Inc. · Calibrator, secondary3 recalls0 reports
- ARCHITECT 08K2803Abbott GmbH · Calibrator, secondary1 recall93 reports
- ARCHITECT 7K63-25Abbott Ireland · CALIBRATOR, SECONDARY108 reports
- VITROS 8067324Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary2 recalls0 reports
- VITROS 8568040Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, SECONDARY1 recall18 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.