Hytec Specific/Total IgE EIA 74154Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816879022100), received between Jul 11, 2018 and Jul 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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. 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.

• MalfunctionJul 11, 2018Device Damaged Prior to Receipt by User; Manufacturing, Packaging or Shipping Problem; Device Damaged Prior to Receipt by User; Manufacturing, Packaging or Shipping Problem

  THE DISTRIBUTOR REPORTED THE SHIPMENT CONTAINING STOP SOLUTION (1N SODIUM HYDROXIDE) WAS RECEIVED WITH A STAINED CARTON, SUGGESTING LEAKAGE OF AN ITEM IN THE PACKAGE. PHOTOGRAPHIC EVIDENCE PROVIDED BY THE DISTRIBUTOR SHOWED TWO STAINED CARTONS. ONE CARTON WAS STAINED ON THE BOTTOM PANEL, THE SECOND CARTON WAS STAINED ON THE TOP PANEL INDICATING THAT A BOTTLE FROM ONE CARTON LIKELY LEAKED AND STAINED THE LOWER CARTON. PICTURES OF THE STOP SOLUTION BOTTLES SHOWED THAT ONE BOTTLE HAD A VISIBLY LOWER VOLUME THAN THE BOTTLE FROM THE OTHER CARTON. (THE CONTAINER IS FILLED TO 300 ML IN A 500 ML BOTTLE). HYCOR REQUESTED PRODUCTS BE RETURNED FOR INVESTIGATION. HYCOR RECEIVED THE DAMAGED PRODUCTS ON 06/01/2018. THE INVESTIGATION DEMONSTRATED ONE OF THE TWO RETURNED BOTTLES WAS LEAKING AS DETERMINED BY A VACUUM TEST. THERE WERE NO ADVERSE OUTCOMES REPORTED TO HYCOR. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, WE ARE FILING AN MDR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679461 ↗