Cardiac CReactive Protein Latex High Sensitive 4628918190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630921508), received between Oct 19, 2023 and Dec 6, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION OF A HIGH RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT SERUM SAMPLE TESTED WITH CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE (CRPHS) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. INITIAL RESULT: 1146.2 MG/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT WAS HIGH AND DID NOT CORRESPOND TO THE PATIENT'S CLINICAL PICTURE. THE PHYSICIAN ALSO REQUESTED A REPEAT OF THE SAMPLE. 1ST REPEAT RESULT: 1171.5 MG/L. 2ND REPEAT RESULT: 114.5 MG/L (TESTED WITH 1:15 DILUTION). 3RD REPEAT RESULT: 116.1 MG/L (TESTED WITH 1:15 DILUTION). THE 2ND AND 3RD REPEAT RESULTS CORRESPONDED TO THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864455 ↗
• MalfunctionNov 20, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CRP LX HS RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 63.55 MG/L WITH A DATA FLAG. THE 1:15 AUTO-DILUTED RESULT WAS 10.8 MG/L. THE REPEAT RESULT WITH A 1:3 DILUTION WAS 65.89 MG/L WITH A DATA FLAG. THE 1:15 AUTO-DILUTED RESULT WAS 10.3 MG/L. THE RESULT USING A 1:5 DILUTION WAS 45.64 MG/L. THE RESULT USING A 1:10 DILUTION WAS 15.38 MG/L. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173411 ↗
• MalfunctionOct 19, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CRPHS ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 589.14 MG/L ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:20 DILUTION AND THE RESULT WAS 281.10 MG/L. THE SAMPLE WAS THEN REPEATED USING "IFI" TECHNOLOGY AND THE RESULT WAS 137.4 MG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. ON (B)(6) 2023 THE SAMPLE WAS REPEATED AND THE RESULT WAS 580.97 MG/L ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED AGAIN WITH A 1:20 DILUTION AND THE RESULT WAS 275.35 MG/L. ADDITIONAL RESULTS WERE PROVIDED FROM 28-SEP-2023: THE RESULT WAS 596.94 MG/L ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE REPEAT RESULT IN DECREASED MODE WAS 272.58 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965983 ↗