STA R Max® (with cap piercing option) 59027Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03607450590272), received between Oct 28, 2022 and Aug 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K082675, K093001, K151867, K212183, K983460); they may or may not involve this specific model.

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.

• MalfunctionAug 10, 2023Low Test Results; Low Test Results

  ON (B)(6) 2023, THE INSTRUMENT PRODUCED A HEPARIN (UFH) RESULT FOR 1 PATIENT (ID: (B)(6)) :UFH = 0.00 UI/ML (<0.1 UI/ML). PHARMACY QUESTIONED THE RESULT WHICH CAUSED THE LABORATORY TO RERUN THE SAMPLE. SAMPLE WAS RERAN ON THE SAME INSTRUMENT, THE RESULT WAS 0.76 UI/ML. SAMPLE WAS CAPPED. ACCORDING TO THE CUSTOMER, THE ERRONEOUS RESULT HAS BEEN RELEASED BUT TREATMENT WAS NOT CHANGED. NO SERIOUS INJURY OR DEATH HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497291 ↗
• MalfunctionOct 28, 2022False Negative Result; False Negative Result

  ON (B)(6) 2021, THE INSTRUMENT PRODUCED A CRITICAL HEPARIN (UFH) RESULT FOR 1 PATIENT :UFH = 0 UI/ML. THE SAMPLE WAS REMOVED FROM THE UNIT AND WAS CHECKED FOR CLOTS, RE-SPUN, AND RERUN WITHOUT THE CAP AND FOUND AT 0.78 UI/ML. ACCORDING TO THE CUSTOMER, THE ERRONEOUS RESULT WAS NOT RELEASED AND NO SERIOUS INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691065 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082675, K093001, K151867, K212183, K983460. One submission often covers many models, so check the product and lot details in each record.

• Z-1575-2023 · Mar 22, 2023 · Open, Classified
  STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
• Z-0899-03 · Mar 5, 2003 · Terminated
  STA-Compact Hemostasis System with Cap piercing capability.