STA Satellite® 58104Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03607450581041), received between May 5, 2020 and May 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K082248); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 21, 2025Open, Classified

   Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

   Z-2473-2025 · Root cause: Mixed-up of materials/components · FDA record ↗

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.

• InjuryMay 5, 2020Incorrect Measurement; Incorrect Measurement

  ON (B)(6) 2020, CUSTOMER RELEASED AN INR GREATER THAN 16.0 FOLLOWING TWO REPEATED VMAX ERROR ON THE PT TEST. ACCORDING TO THE CUSTOMER, QUALITY CONTROL BEFORE AND AFTER THE RESULTS WERE IN RANGE. CUSTOMER PERFORMED THE MAINTENANCE OF THE INSTRUMENT AND REPEATED AGAIN THE TEST: INR= 2.4. THE CORRECTED RESULT WAS CALLED TO PROVIDER: NO CHANGE MADE TO PATIENT THERAPY DUE TO THE INITIAL RESULT. THEN ON (B)(6) 2020, QC FOR PT AND PTT WERE IN VMAX ERROR. QC REPEATED WITHIN RANGE BUT AFTER A THIRD RUN, PTT QC WERE IN VMAX AGAIN. INSTRUMENT TAKEN OUT OF SERVICE AND SAMPLES FROZEN. A TECHNICAL INTERVENTION HAS BEEN ASKED AND PERFORMED THE SAME DAY: THE TECHNICIAN FOUND A NEEDLE CLOGGED AND REPLACED NEEDLE FROM CUSTOMER INVENTORY. PRELIMINARY CONCLUSION: THE MOST LIKELY ROOT CAUSE WAS A CLOGGED NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10024815 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082248. One submission often covers many models, so check the product and lot details in each record.

• Z-0252-2013 · Jun 15, 2012 · Terminated
  STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the resu