ImmunoCard STAT! EHEC 751630Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840733101366), received between Sep 29, 2017 and Sep 29, 2017 — classified as 1 death.

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

• DeathSep 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER BECAME AWARE OF DEATH OF (B)(6) YEAR OLD, FEMALE DUE TO COMPLICATIONS ARISING FROM E. COLI INFECTION, HEMOLYTIC UREMIC SYNDROME (HUS). PATIENT HAD BEEN TESTED USING IMMUNOCARD STAT! EHEC PRODUCT, NEGATIVE RESULTS REPORTED. NOTIFICATION OF PATIENT DEATH WAS RECEIVED ON (B)(6), BY MANUFACTURER PERSONNEL DURING ROUTINE SALES CALL WITH TESTING FACILITY. THE FOLLOWING INFORMATION WAS COLLECTED BY (B)(6). COMPLAINT HANDLING DEPARTMENT (TECHNICAL SERVICE): INSIDE SALES REPRESENTATIVE NOTIFIED TECHNICAL SERVICE THAT CUSTOMER DISCLOSED PATIENT TESTED FOR EHEC AT THEIR FACILITY HAD EXPIRED. PATIENT TEST RESULT WAS REPORTED AS 'NEGATIVE' BY (B)(6) IMMUNOCARD STAT! EHEC, CATALOG 751630. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND WAS TESTED FOR EHEC. PATIENT RESULTS REPORTED AS 'TOXIN 2 POSITIVE' AT OTHER FACILITY. SOMETIME BETWEEN THE INITIAL TESTING AND THE SUBSEQUENT TESTING, PATIENT WAS TREATED WITH ANTIBIOTICS. PATIENT DIED. TECHNICAL SERVICE PERSONNEL CONTACTED CUSTOMER AS FOLLOW-UP. TECHNICAL SERVICE WAS ADVISED BY THE CUSTOMER THAT THEY WERE NOT ABLE TO GIVE ANY ADDITIONAL DETAILS REGARDING THE SITUATION. TECHNICAL SERVICE PERSONNEL REVIEWED TESTING AND PROCEDURE WITH

  Patient problems: Death

  MAUDE report 6906530 ↗