CoaguChek XS Plus Professional Care Kit 04562780001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630945726), received between Dec 2, 2021 and Oct 17, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K071041); 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. 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.

• MalfunctionOct 17, 2023Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH COAGUCHEK XS PLUS METER SERIAL NUMBER (B)(6). THE CUSTOMER STATED THE METER DISPLAY LOOKS BLURRY AND SOMETIMES THE DISPLAY IS CHOPPY AND DIFFICULT TO READ. NO MISINTERPRETATION OF RESULTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949474 ↗
• MalfunctionApr 21, 2022Failure to Transmit Record; Failure to Transmit Record

  THERE WAS AN ALLEGATION OF AN ISSUE WITH THE SOFTWARE FOR A COAGUCHEK XS PLUS METER. A METER RESULT OF 2.4 INR WAS TAKEN ON (B)(6) 2022 AT 00:03. THE CUSTOMER COULD NOT FIND THE RESULT IN THEIR (RALS) SYSTEM. UPON REVIEW OF THE METER MEMORY, THE RESULT WAS IN THE METER MEMORY AS BEING TAKEN ON (B)(6) 2021. THE RESULT WAS TRANSFERRED TO THE CORRECT PATIENT BUT HAD THE WRONG DATE. THE TEST STRIP LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. THE PATIENT'S THERAPEUTIC RANGE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14170395 ↗
• MalfunctionDec 2, 2021Circuit Failure; Circuit Failure

  THERE WAS AN ALLEGATION OF A METER MEMORY ISSUE WITH A COAGUCHEK XS PLUS METER. THE CUSTOMER REVIEWED THE METER'S MEMORY AND NOTICED TWO RESULTS FROM TWO PATIENTS ON (B)(6) 2021 WERE MISSING. THE TWO RESULTS WERE 1.9 INR AT 09:29 AND 2.5 INR AT 10:50. THE CUSTOMER CONFIRMED THERE WERE NO MISSING PIXELS FROM THE DISPLAY, THE RESULTS FOUND IN THE METER'S MEMORY WERE ABLE TO BE READ, AND THE DATE WAS SET CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915265 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071041. 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-1583-2013 · May 16, 2013 · Terminated
  CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy
• Z-2004-2009 · Jul 22, 2009 · Terminated
  Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001. CoaguChek XS System and CoaguChek XS Plus System are point of