STA R Max® (with cap piercing option) 59010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03607450590104), received between Oct 4, 2019 and Oct 16, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K082675, K093001, K151867, 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.

• MalfunctionOct 16, 2019Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A CUSTOMER (B)(6)) CALLED THE (B)(6) ON (B)(6) 2019 TO REPORT A BIAS OF -100% ON STAGO 1 (S/N (B)(4)) VS. STAGO 2 (S/N (B)(4)) FOR PROTEIN C TESTING. THE PC RESULTS FROM (B)(6) 2018 UNTIL (B)(6) 2019 ON STAGO 1 (S/N (B)(4)) WERE RECOVERING APPROXIMATELY HALF OF EXPECTED LEVELS DUE TO AN INCORRECT DILUTION FACTOR SETTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9195643 ↗
• InjuryOct 4, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER (CPL - SONIC) CALLED THE STAGO NORTH AMERICA HOTLINE ON (B)(6) 2019 TO REPORT A BIAS OF -100% ON STAGO 1 (S/N (B)(4)) VS. STAGO 2 (S/N (B)(4)) FOR PROTEIN C TESTING. THE PC-20 RESULTS FROM 19JUL2018 UNTIL 06SEP2019 ON STAGO 1 (S/N (B)(4)) WERE RECOVERING APPROXIMATELY HALF OF EXPECTED LEVELS DUE TO AN INCORRECT DILUTION FACTOR SETTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158233 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082675, K093001, K151867, 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.