Thermo Scientific Trutol™ 401272PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845275004090), received between Oct 1, 2019 and Oct 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 18, 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.

• MalfunctionOct 1, 2019Device Markings/Labelling Problem

  (B)(6) HOSPITAL PLACED AN ORDER WITH A DISTRIBUTOR, (B)(4), FOR ORANGE-FLAVORED TRUTOL GLUCOSE TOLERANCE TEST BEVERAGE WITH 100G OF DEXTROSE. (B)(6) HOSPITAL STAFF DISCOVERED THAT THEY WERE SUPPLIED WITH 50G DEXTROSE BOTTLES INSTEAD OF 100G DEXTROSE BOTTLES APPROXIMATELY ONE MONTH AFTER RECEIPT OF THE PRODUCT. THE SUPPLIER, (B)(4), WAS CONTACTED AND CONFIRMED THAT THE AFOREMENTIONED SHIPMENT TO (B)(6) HOSPITAL WAS MADE IN ERROR. (B)(6) HOSPITAL NOTIFIED PATIENTS WHO HAD BEEN TESTED FOR GLUCOSE TOLERANCE WITH THIS BEVERAGE AND ASKED THE PATIENTS TO RETURN FOR REPEAT TESTING. (B)(6) HOSPITAL HAS CONFIRMED THAT THERE HAVE BEEN NO ADVERSE EFFECTS AS A RESULT OF INCORRECT ADMINISTRATION OF THE TRUTOL GLUCOSE TOLERANCE TEST BEVERAGE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9139107 ↗