BACT/ALERT® FNRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026595920), received between Dec 18, 2020 and Dec 18, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unable to Obtain Readings” (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 16, 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.

• MalfunctionDec 18, 2020Unable to Obtain Readings; Unable to Obtain Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A BLOOD CULTURE SAMPLE CLOTTING IN ASSOCIATION WITH THE BACT/ALERT® FN PLASTIC BOTTLE (REFERENCE # 259793, LOT # 0001055186). THE INITIAL COMPLAINT FROM THE CUSTOMER MENTIONED A BOTTLE RECEIVED WITHOUT AGAR PRESENT. THIS WAS NOTICED BY THE TECHNICIAN PRIOR TO LOADING THE BOTTLE IN THE INSTRUMENT AND A SECOND SAMPLE WAS ABLE TO BE TAKEN WITHOUT CAUSING A DELAY. THERE WAS NO PATIENT HARM OR IMPACT. THE CUSTOMER LATER CONFIRMED THAT THE DESCRIPTION OF THEIR INITIAL COMPLAINT WAS SUPPOSED TO BE FOR A BLOOD CLOT GENERATED IN THE BOTTLE. THE SAMPLE HAD CLOTTED IN THE IMPACTED BOTTLE. THE CUSTOMER STATED THAT AN ON-SITE INVESTIGATION FOUND THE CLOTTING ISSUE WAS DUE TO OPERATOR ERROR RATHER THAN A PRODUCT ISSUE. THE USER DID NOT SHAKE THE BOTTLE EVENLY AFTER COLLECTING A BLOOD SAMPLE. HOWEVER, THERE ARE NO INSTRUCTIONS IN THE BACT/ALERT BOTTLE PACKAGE INSERT REQUIRING SHAKING OR INVERTING THE TUBE FOR COLLECTION. RATHER, THE BOTTLES ARE CONSTANTLY AGITATED WHEN LOADED IN TO THE MACHINE. IT IS POSSIBLE THAT OTHER STEPS IN THE BLOOD SAMPLE COLLECTION PROCESS MAY HAVE LED TO THE SAMPLE CLOTTING. THE CUSTOMER NOTED THAT THEY DIRECTLY COLLECTED BLOOD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11041752 ↗