Kallestad 29403Recalls & reported problems
Bio-Rad Laboratories, Inc. · Kallestad Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Ethanol IFA · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847817016103), received between Nov 15, 2018 and Nov 15, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER IS A NURSE. WHEN OPENING THE FRIDGE, ANCA OR HEP-2 SLIDES FELL (ABOUT 4 TO 5 SLIDES). ATTEMPTING TO PICK UP THE BROKEN SLIDES THE CUSTOMER CUT HERSELF ALTHOUGH SHE WAS WEARING PROTECTIVE GLOVES. THE CUSTOMER WASHED HER HANDS THOROUGHLY WITH SOAP AND LEFT HER FINGER IN THE ALCOHOL FOR ABOUT 40 MINUTES. A SEROLOGY CHECK WILL BE DONE IN 7 WEEKS. THE CUSTOMER WENT TO SEE A DOCTOR. THE DOCTOR HAS ASSURED THE CUSTOMER THAT THERE IS NO HIV RISK , BECAUSE THE SLIDES WERE OLD AND DATED AS OF 2012. CUSTOMER WAS INJURED ON (B)(6) 2018. (B)(6) CUSTOMER REP (B)(6) WILL CONTACT CUSTOMER FOR FOLLOWUP INFORMATION IN 7 WEEKS.
Patient problems: Injury
MAUDE report 8075780 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.