CReactive Protein Latex) 20764930322Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630913633), received between Jul 26, 2018 and Jan 25, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS HIGH RESULTS WERE GENERATED BY MULTIPLE ANALYZERS. THE FIRST AND THIRD SAMPLES WERE TESTED ON A COBAS 4000 C (311) STAND ALONE SYSTEM AND A COBAS 6000 C (501) MODULE. THE SECOND SAMPLE WAS TESTED ON TWO UNKNOWN ROCHE ANALYZERS. THE EVENT INVOLVED THREE SAMPLES FROM 1 PATIENT TESTED WITH CRPLX C-REACTIVE PROTEIN (LATEX). THE PATIENT'S AGE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED BUT WAS NOT PROVIDED. 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 8278612 ↗
• MalfunctionJul 26, 2018Low Test Results; Low Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE LOW GLUC3 GLUCOSE HK AND CRPLX C-REACTIVE PROTEIN RESULTS FOR ONE PATIENT SAMPLE FROM THE COBAS 6000 C 501 MODULE. THE INITIAL GLUCOSE RESULT WAS 4.5 MG/DL AND THE REPEAT RESULT WAS 117.5 MG/DL. ON (B)(6) 2018, THE REPEAT RESULT WAS 115 MG/DL. THE INITIAL CRPLX RESULT WAS 1.22 MG/L. THE REPEAT RESULTS ON (B)(6) 2018 WERE 50.26 MG/L AND 50.79 MG/L. ONLY THE ERRONEOUS CRPLX RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE GLUCOSE REAGENT LOT NUMBER WAS 33012601 WITH AN EXPIRATION DATE OF 30-JUN-2019. THE CRPLX REAGENT LOT NUMBER WAS 31645201 WITH AN EXPIRATION DATE OF 30-NOV-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7724156 ↗