CReactive Protein Gen3 5172373190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630925285), received between Sep 19, 2018 and Sep 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

1 other recall cover devices cleared under the same FDA submission (K083444); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE CRPL3 C-REACTIVE PROTEIN GEN.3 RESULTS FROM THEIR COBAS 8000 C (701) MODULE WHERE 26 AMENDED REPORTS HAD TO BE ISSUED. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION OCCURRED FOR 24 PATIENTS. THE CUSTOMER STATED THAT ON THE DAY OF THE EVENT, THE QC RESULTS AT 4:00, 7:00, AND 10:30 WERE ACCEPTABLE. AT 13:30 THE QC RESULTS WERE OUT OF RANGE LOW. THE CUSTOMER TRIED TO CALIBRATE THE PACK OF REAGENT THAT WAS ON THE ANALYZER TWICE, BUT CALIBRATION FAILED BOTH TIMES. A NEW PACK OF REAGENT WAS LOADED AND THE QC RESULTS WERE AGAIN ACCEPTABLE. THE CUSTOMER REPEATED ALL PATIENT SAMPLES THAT WERE TESTED BETWEEN 10:30 AND 13:30 AND THE DISCREPANT PATIENT RESULTS WERE FOUND. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS C701 SERIAL NUMBER WAS (B)(4). ON (B)(6) 2018 THE CUSTOMER REPORTED ANOTHER SIMILAR INCIDENT WHERE THE CRPL3 QC RESULTS WERE LOW AND ACCEPTABLE RESULTS COULD NOT BE OBTAINED UNTIL A FRESH PACK OF REAGENT WAS USED. NO PATIENT SAMPLES WERE AFFECTED. THIS ISSUE IS ONLY OCCURRING ON ONE INSTRUMENT. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7890370 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083444. One submission often covers many models, so check the product and lot details in each record.

• Z-0634-2021 · Nov 6, 2020 · Terminated
  Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinica