STA Compact Max® (with cap piercing option) 58989Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03607450589894), received between Dec 23, 2021 and May 13, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  ON (B)(6) 2026, ON STA COMPACT MAX SN (B)(6), PT = 78.9 S, 10.1 (INR), PTT = 81.7S / FIB = 142MG/DL HAS BEEN PRODUCED FOR PATIENT SID (B)(6). RERAN ON THE SAME INSTRUMENT : PT = 28.4S/2.7 (INR) / FIB = 135MG/DL THEN RERAN ON ANOTHER INSTRUMENT (STA COMPACT MAX SN (B)(6)): PT = 29.3S/2.80 (INR) PTT = 56.4S / FIB = 165 MG/DL. ON (B)(6) 2026, ON THE SAME INSTRUMENT, TWO OTHER PATIENTS WERE AFFECTED BY ERRONEOUS RESULTS ON STA COMPACT MAX SN (B)(6): - SID (B)(6) WITH PT = 116.6S, 16.81 (INR)/ PTT = 33.5S/ FIB = 332MG/DL. RERAN ON THE SAME INSTRUMENT : PT = 26.4S, 2.43(INR) / PTT = 37.3S / FIB = 304 MG/DL THEN RERAN ON ANOTHER INSTRUMENT (STA COMPACT MAX SN (B)(6)): PT = 19.6S, 1.66 (INR) / PTT = 35 S / FIB = 402 MG/DL. - SID (B)(6) WITH PT = 42.0S, 4.45(INR). RERAN ON THE SAME INSTRUMENT : PT = 35.0S, 3.52 (INR) THEN RERAN ON ANOTHER INSTRUMENT (STA COMPACT MAX SN (B)(6)): PT = 35.6S, 3.59 (INR). THE ERRONEOUS RESULTS PRODUCED ON STA COMPACT MAX SN (B)(6) WERE NOT RELEASED. ONLY REPEATED RESULTS ON STA COMPACT MAX (B)(6) WERE REPORTED. NO CHANGE IN TREATMENT WAS OBSERVED. ON APRIL 17, 2026, THE MANUFACTURER'S REVIEW OF INSTRUMENT DATA FILES REVEALED INCONSISTENT AND INACCURATE PIPETTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162450 ↗
• InjuryJun 18, 2025Low Test Results; Low Test Results

  THROUGH THE TROUBLESHOOTING TO DETERMINE THE ROOT CAUSE FOR A PROFICIENCY (API 2025 HEMATOLOGY/COAGULATION-1ST EVENT) FAILURE ON INR, CUSTOMER REALIZED THAT THE ISI VALUE FOR STA NEOPLASTINE CI + (LOT 270708) WAS INCORRECT. DURING THE NEW LOT REAGENT CHANGE, AN ERRONEOUS VALUE OF 1.00 FOR ISI WAS INADVERTENTLY ENTERED BY THE LABORATORY INSTEAD OF APPLYING THE BAR-CODED ISI VALUE FOR THIS LOT (WHICH WAS SUPPOSED TO BE 1.31). CUSTOMER CORRECTED THE VALUE ON (B)(6) 2025, 11:50 AM (FROM 1.00 TO 1.31). THE INSTRUMENT FILE DATA ANALYSIS SHOWED THAT THE INCORRECT ISI VALUE HAD BEEN SET ON (B)(6) 2024 07:04 AM. THE CUSTOMER RECALCULATED THE INR VALUES THAT WERE REPORTED BETWEEN (B)(6) 2024 AND (B)(6) 2025 AND COMPLETED THE PATIENT IMPACT ASSESSMENT. ACCORDING TO THIS EVALUATION, THE CUSTOMER'S ANTICOAGULATION PHARMACY IDENTIFIED ONE CASE OF SERIOUS INJURY, POTENTIALLY RELATED TO THE ERRONEOUS ISI VALUE. BASED ON ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER EMDR THAT STAGO RECEIVED FROM FDA ON 10JUNE2025 (REF# MW5170914 -FOI), "THE DAY PRIOR TO PATIENT'S ADMISSION ((B)(6) 2025), THE INR WAS 2.7 TO TARGET OF 2.5 / 3.5 (WHEREAS WITH CORRECT ISI, INR = 3.7, ABOVE THE TARGET). THE DAY OF P

  Patient problems: Hematoma

  MAUDE report 22283375 ↗
• InjuryJun 18, 2025Low Test Results; Low Test Results

  THROUGH THE TROUBLESHOOTING TO DETERMINE THE ROOT CAUSE FOR A PROFICIENCY (API 2025 HEMATOLOGY/COAGULATION-1ST EVENT) FAILURE ON INR, CUSTOMER REALIZED THAT THE ISI VALUE FOR STA NEOPLASTINE CI + (LOT 270708) WAS INCORRECT. DURING THE NEW LOT REAGENT CHANGE, AN ERRONEOUS VALUE OF 1.00 FOR ISI WAS INADVERTENTLY ENTERED BY THE LABORATORY INSTEAD OF APPLYING THE BAR-CODED ISI VALUE FOR THIS LOT (WHICH WAS SUPPOSED TO BE 1.31). CUSTOMER CORRECTED THE VALUE ON (B)(6) 2025 11:50 AM (FROM 1.00 TO 1.31). THE INSTRUMENT FILE DATA ANALYSIS SHOWED THAT THE INCORRECT ISI VALUE HAD BEEN SET ON (B)(6) 2024 07:04 AM. THE CUSTOMER RECALCULATED THE INR VALUES THAT WERE REPORTED BETWEEN (B)(6) 2024, AND (B)(6) 2025, AND COMPLETED THE PATIENT IMPACT ASSESSMENT. ACCORDING TO THIS EVALUATION, THE CUSTOMER'S ANTICOAGULATION PHARMACY IDENTIFIED ONE CASE OF SERIOUS INJURY, POTENTIALLY RELATED TO THE ERRONEOUS ISI VALUE. BASED ON ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER EMDR THAT STAGO RECEIVED FROM FDA ON 10JUNE2025 (REF# MW5170914 -FOI), "THE DAY PRIOR TO PATIENT'S ADMISSION ((B)(6) 2025), THE INR WAS 2.7 TO TARGET OF 2.5 / 3.5 (WHEREAS WITH CORRECT ISI, INR = 3.7, ABOVE THE TARGET). THE DAY OF

  Patient problems: Hematoma

  MAUDE report 22269283 ↗
• MalfunctionApr 4, 2024Low Test Results; Low Test Results

  ON 2024-01-10, THE ANALYZER (STA COMPACT MAX (B)(6) ) PRODUCED ERRONEOUS RESULTS IN HEPARIN (UFH) FOR 3 PATIENTS : - PATIENT 1 (ID=(B)(6) ) : UFH = 0.77 UI/ML, RERUN ON THE SAME ANALYZER, UFH = <0.10 UI/ML. RESULT WAS NOT RELEASED. SAMPLE WAS RERUN ON A SECOND ANALYZER UFH = 0.31 UI/ML . - PATIENT 2 (ID=(B)(6) ) : THE SAMPLE WAS TESTED FOUR TIMES ON THE SAME ANALYZER. 1. UFH = <0.10 UI/ML 2. UFH = 0.60 UI/ML 3. UFH = <0.10 UI/ML 4. UFH = <0.10 UI/ML. RESULT <0.10 UI/ML. SAMPLE WAS RERUN ON A SECOND ANALYZER, UFH = 0.55 UI/ML. THE CUSTOMER DID NOT SEND THE CLIENT QUESTIONNAIRE DESPITE 3 ATTEMPTS BY THE HOTLINE BUT TO OUR KNOWLEDGE, THERE WAS NO IMPACT ON THE PATIENT HEALTH. NO SERIOUS INJURY OR DEATH HAVE BEEN REPORTED. - PATIENT 3 (ID=(B)(6) ) : THE SAMPLE WAS TESTED 2 TIMES AND GAVE UFH = <0.10 UI/ML. RESULT NOT RELEASED. SAMPLE WAS RERUN ON A SECOND ANALYZER, UFH = 0.72 UI/ML. A SERVICE ENGINEER (FSE) WAS DISPATCHED THE SAME DAY. HE DID A PREVENTIVE MAINTENANCE AND A VALIDATION OF HEPARIN TEST, WHICH WASN'T CONFORM. THE FSE REQUESTED THE CUSTOMER TO NO LONGER RUN HEPARIN TESTS ON THE INSTRUMENT UNTIL HE COMES BACK. THE FSE WAS DISPATCHED AGAIN ON THE 23TH OF JANUARY. HE DID AN AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039244 ↗
• MalfunctionFeb 27, 2023Low Test Results; Low Test Results

  ON (B)(6) 2023, THE INSTRUMENT PRODUCED CRITICAL HEPARIN (UFH) RESULTS FOR 4 PATIENTS :UFH = 0.00 UI/ML. WHEN SAMPLES WERE RERAN, THE RESULTS WERE AS FOLLOW: A. INITIAL RESULT: <0.10, CORRECTED: 0.49 DRAWN DATE/TIME: ORIGINAL: (B)(6) 2023 @ 06:31 CORRECTED: 10:00; B. INITIAL RESULT: <0.10, CORRECTED: 0.82 DRAWN DATE/TIME: ORIGINAL: (B)(6) 2023 @ 06:05 CORRECTED: 09:29; C. INITIAL RESULT: <0.10, CORRECTED: 0.17 DRAWN DATE/TIME: ORIGINAL: (B)(6) 2023 @ 07:22 CORRECTED: 09:36; D. INITIAL RESULT: <0.10, CORRECTED: 0.68 DRAWN DATE/TIME: ORIGINAL: (B)(6) 2023 @ 07:22 CORRECTED: 09:39. SAMPLES WERE UNCAPPED. ACCORDING TO THE CUSTOMER, RESULTS HAVE BEEN RELEASED, AND PATIENT(S) RECEIVED TREATMENT OR HAD TREATMENT WITHHELD BASED ON THE RESULTS REPORTED. DIAGNOSTICA STAGO HAS RECEIVED NO DETAILS OF TREATMENT(S) CHANGES. NO SERIOUS INJURIES OR DEATHS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443703 ↗
• InjuryDec 23, 2021Incorrect Measurement; Incorrect Measurement

  FOUR ERRONEOUS UFH RESULTS WITH STA LIQUID ANTI-XA REAGENT ON STA COMPACT MAX ANALYZER WERE REPORTED. ALL OF THEM WERE FALSELY <0.1 IU / ML RESULTS (ABSENCE OF HEPARIN). ON (B)(6) 2021 : RESULTS <0.1 IU / ML. THEN, TESTS RERAN THE SAME DAY ON ANOTHER INSTRUMENT: PATIENT 1: RELEASED AT 0.51 IU / ML. PATIENT 2: RELEASED AT 1.11 IU / ML. PATIENTS 1 & 2 HAVE RECEIVED A CHANGE IN THE THERAPY BUT NO SERIOUS INJURY WAS REPORTED. ON (B)(6) 2021: RESULTS <0.1 IU / ML. THEN, TESTS RERAN 30MIN LATER ON THE SAME INSTRUMENT: PATIENT 3: RELEASED AT 0.33 IU / ML. PATIENT 4: RELEASED AT 0.21 IU / ML. NO INFORMATION ABOUT ANY CHANGES IN TREATMENT FOR THESE PATIENTS. NO SERIOUS INJURY TO OUR KNOWLEDGE. THE INTERNAL QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES BEFORE AND AFTER THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13073476 ↗