BenchMark ULTRA PLUS Instrument 09576797001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336184608), received between Apr 24, 2025 and Sep 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Computer Software 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Computer Software Problem

  There was an allegation of a reagent position issue during a run with the BenchMark Ultra Plus Instrument.The customer started a run at 6:48 a.m. with two slides, but all necessary reagents were on board for additional slides. They added 11 more slides around 7:23. The customer scheduled a Reagent Access Point (RAP) for 11:12. The customer always uses the software to tell them what position a reagent is in for removal. When they went to remove the reagent, it was not in the position that the software indicated. The majority of the slides started at 7:23 had completed staining, and upon reviewing the slides, they found that none had stained appropriately. The customer had 7 trays loaded and all reagents were shifted one position.After the RAP was completed, the customer returned to the software and found that the reagents were now in the correct position on the software. There were 2 slides put onto the instrument at 8:55 and 9:56 and the staining for these two slides was okay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688195 ↗
• MalfunctionApr 24, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE STAINING FOR 2 PATIENT SAMPLES TESTED FOR CONFIRM ANTI-PROGESTERONE RECEPTOR (PR) (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY ON A BENCHMARK ULTRA PLUS INSTRUMENT. FOR BOTH PATIENTS, THE POSITIVE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. TESTING WAS REPEATED AS THE PATHOLOGISTS NOTED UNEXPECTED STAINING ON SLIDES PROCESSED BETWEEN THE AFTERNOON ON (B)(6) 2025 AND THE MORNING ON (B)(6) 2025. UPON REPEAT STAINING, THE RESULTS FOR BOTH PATIENTS WERE NEGATIVE. AMENDED REPORTS WERE SENT OUT. CONTROLS WERE USED AND SHOWED ACCEPTABLE STAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899904 ↗