Lithium 4679598190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630921669), received between Jan 25, 2019 and Feb 3, 2023 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LI LITHIUM ON A COBAS 6000 C (501) MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 1.64 MG/DL. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 0.31 MGDL. THE REPEAT VALUE WAS CONSIDERED CORRECT AND WAS RELEASED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL. THE LITHIUM REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16299167 ↗
• MalfunctionDec 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE LI LITHIUM RESULTS FOR ONE PATIENT SAMPLE WITH A COBAS 6000 C 501 MODULE. THE INITIAL RESULT WAS 1.62 MMOL/L. THE REPEATED RESULT WAS 1.61 MMOL/L. THE CLINICIAN QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT¿S CONDITION SO THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING. THE RESULT FROM THE OTHER LABORATORY USING AN UNKNOWN METHOD WAS 0.6 MMOL/L. THE REAGENT LOT NUMBER WAS 542029. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119011 ↗
• MalfunctionJan 25, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY THE COBAS 6000 C (501) MODULE. THE EVENT INVOLVED 1 PATIENT WITH ERRONEOUS RESULTS FOR LI LITHIUM THAT DID NOT CORRELATE WITH THE PATIENT'S TREATMENT. THE PATIENT'S AGE WAS (B)(6). THE PATIENT'S GENDER WAS MALE. THE PATIENT'S RACE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8278635 ↗