Anti-s (Monoclonal) Gamma-clone 0004815Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888234002215), received between Jan 14, 2019 and Jul 30, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2020False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING ANTI-S MONOCLONAL GAMMA-CLONE REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED AN UNEXPECTED NEGATIVE RESULTS FOR THE ANTI-S ANTIBODY. THE RESULTS REPRESENTED A FALSE NEGATIVE DUE TO PRIOR PATIENT HISTORY OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODY. SUBSEQUENT TESTING OF THE REAGENT RETENTION LOT AND AN ANTIGEN VALIDATION TEST OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10347314 ↗
• MalfunctionJan 14, 2019False Negative Result; False Negative Result

  ON (B)(6) 2018 A CUSTOMER REPORTED A TYPING DISCREPANCY FOR LITTLE S ON A PATIENT SAMPLE WHEN USING GAMMA-CLONE ANTI-S BLOOD GROUPING REAGENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243856 ↗