CoaguChek XS Pro Kit 5530199160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00365702398108), received between Aug 1, 2018 and Aug 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unauthorized Access to Computer System” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K093460, K180693); 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.

• MalfunctionAug 1, 2018Unauthorized Access to Computer System; Unauthorized Access to Computer System

  AN INTERNAL INVESTIGATION HAS DETERMINED THAT COAGUCHEK XS PRO METERS ARE VULNERABLE TO A CYBERSECURITY OR DATA BREACH. THIS WAS DISCOVERED DURING ROCHE INTERNAL INVESTIGATIONS IN CONJUNCTION WITH A CYBERSECURITY CONSULTANT. THE INTERNAL INVESTIGATION DETERMINED THAT SIGNIFICANT PRODUCT AND CYBERSECURITY KNOWLEDGE IS NEEDED TO EXPLOIT THESE VULNERABILITIES. THE CONSULTANT WAS ABLE TO REVERSE ENGINEER THE SERVICE PASSWORD GENERATOR. THE CONSULTANT WAS ALSO ABLE TO EXECUTE CODE THROUGH A HIDDEN COMMAND. THE INVESTIGATION DETERMINED THE FOLLOWING: -DELETION OF PROTECTED HEALTH INFORMATION MAY BE POSSIBLE, -MODIFICATION OF PROTECTED HEALTH INFORMATION MAY BE POSSIBLE, -CHANGING THE UNITS OF MEASURE MAY BE POSSIBLE, -THE VULNERABILITIES CAN BE EXPLOITED INDEPENDENTLY OR IN COMBINATION. IN THE WORST CASE SCENARIO, THE MEDICAL RISK IS HIGH. THE PROBABILITY OF THIS TYPE OF EVENT OCCURRING IS LOW (CRIMINAL INTENT, THEFT OF THE DEVICE, ENTERING THE FIREWALL, ETC.). THE LIKELIHOOD OF OCCURRENCE OF A SUCCESSFUL ATTACK IS DEEMED LOW TO THEORETICAL WITH INSTALLATIONS SECURED IN ACCORDANCE WITH ROCHE CYBER SECURITY RECOMMENDATIONS. THERE HAVE BEEN NO REPORTS OF ACTUAL OCCURRENCE IN THE FIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7740438 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093460, K180693. One submission often covers many models, so check the product and lot details in each record.

• Z-0360-2019 · Sep 13, 2018 · Terminated
  CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS P
• Z-1582-2013 · May 16, 2013 · Terminated
  CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blo
• Z-1114-2013 · Mar 6, 2013 · Terminated
  CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").