CalSet Vitamin D total III 09038116190Recalls & reported problems
Roche Diagnostics GmbH · Vitamin D total G3 CS Elecsys · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07613336172667), received between Dec 20, 2021 and Dec 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Low Test Results1
- Non Reproducible Results1
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.
MalfunctionDec 20, 2021Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results
THE INITIAL REPORTER ALLEGES THERE IS AN ISSUE WITH THE ELECSYS VITAMIN D GEN. 3 CALSET LOT 525313. THE REPORTER STATED THEY STARTED USING THE CALIBRATOR LOT IN (B)(6) 2021 AND PRECISION WAS POOR. THE CUSTOMER SWITCHED TO ANOTHER LOT OF CALIBRATOR AND VALIDATIONS PERFORMED WITH THIS LOT WERE APPROVED. THE REPORTER STATED THEY STARTED USING CALIBRATOR LOT 525313 AGAIN STARTING ON (B)(6) 2021. IN THE FOLLOWING DAYS, THE REPORTER STATED THEY RECEIVED QUESTIONABLE LOW PATIENT RESULTS FOR APPROXIMATELY 200 PATIENT SAMPLES TESTED WITH THE ELECSYS VITAMIN D GEN. 3 ASSAY. THE REPORTER PROVIDED SPECIFIC DATA FOR SIX PATIENT SAMPLES THAT HAD DISCREPANT VITAMIN D RESULTS. THE SAMPLES WERE INITIALLY TESTED AT THE CUSTOMER SITE ON A COBAS 8000 E 602 MODULE (SERIAL NUMBER (B)(4)) ON (B)(6) 2021. THE INITIAL MEASUREMENTS WERE REPORTED OUTSIDE OF THE LABORATORY TO A CLINICIAN. THE FIRST SAMPLE WAS REPEATED AT THE CUSTOMER SITE ON THE SAME E602 ANALYZER ON (B)(6) 2021. SAMPLES 2-6 WERE SENT TO A SECOND SITE FOR REPEAT TESTING ON A COBAS 6000 E 601 MODULE (SERIAL NUMBER (B)(4)) ON (B)(6) 2021. ALL REPEAT VALUES WERE BELIEVED TO BE CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13043023 ↗
Other Calibrator, secondary devices
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
- ARCHITECT 8K28-02Abbott Laboratories · CALIBRATOR, SECONDARY1 recall115 reports
- BioPlex 2200 12000651Bio-Rad Laboratories, Inc. · Calibrator, secondary3 recalls0 reports
- VITROS 8231474Ortho-Clinical Diagnostics, 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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