Lithium 08057974190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336121382), received between Dec 15, 2022 and Oct 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LITHIUM ON A COBAS C 703 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 2.43 NMOL/L AND IT REPEATED AS 0.94 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350214 ↗
• MalfunctionMar 19, 2024Unable to Obtain Readings; Low Test Results; Unable to Obtain Readings; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LITHIUM RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.1 MMOL/L WITH A DATA FLAG AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT DID NOT MATCH THE PATIENT'S HISTORY AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 2.3 MMOL/L AND WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933199 ↗
• MalfunctionFeb 28, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH LI LITHIUM ON A COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. DUE TO PREVIOUS ISSUES, THE SAMPLES WERE REPEATED ON A SECOND ANALYZER ON 03-FEB-2023 AND THESE VALUES WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 1.2 MMOL/L AND REPEATED AS 0.7 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 1.9 MMOL/L AND REPEATED AS 0.6 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456723 ↗
• MalfunctionDec 15, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LITHIUM (LI) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.28 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 0.00524 MMOL/L WITH A DATA FLAG. THE CUSTOMER REPEATED THE SAMPLE 5 TIMES WITH RESULTS OF 0.0173 MMOL/L WITH A DATA FLAG, 0.0190 MMOL/L WITH A DATA FLAG, 0.0183 MMOL/L WITH A DATA FLAG, 0.0141 MMOL/L WITH A DATA FLAG, AND 0.0160 MMOL/L WITH A DATA FLAG. THE REPEAT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT CLEAR WHICH RESULTS WERE BELIEVED TO BE CORRECT. THE LI REAGENT LOT NUMBER WAS 59094201 WITH AN EXPIRATION DATE OF 30-SEP-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991887 ↗