Access BNP 98200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590750947), received between Feb 12, 2025 and Mar 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “High Test Results” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryMar 30, 2026High Test Results

  ON 17MAR2026, THE CUSTOMER REPORTED INCONSISTENT BNP RESULTS (PART NUMBER 98200, LOT NUMBER 538343) FOR ONE PATIENT INVOLVING THEIR UNICEL DXI 800 INSTRUMENT (PART NUMBER A71456 AND SERIAL NUMBER (S/N) (B)(6). CUSTOMER STATED PATIENT WAS BEING TREATED AND WAS "GIVEN A BUNCH OF MEDS" BASED ON THE 793 PG/ML RESULT. NO FURTHER INJURY TO PATIENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2026, THE INITIAL BNP RESULT WAS 39 PG/ML (05:05 AM) ON THE DXI 800 S/N (B)(6). ANOTHER ALIQUOT FROM THE SAME PRIMARY TUBE WAS SPUN DOWN 5 HOURS LATER AND RUN ON THE DXI 800 ANALYZER (SERIAL NUMBER (B)(6), RESULTING IN 793.3 PG/ML (RESULT QUESTIONED) (10:22 AM). A THIRD SAMPLE WAS DRAWN, ALIQUOTED, SPUN DOWN, AND RUN ON THE ANALYZER SERIAL NUMBER (B)(6), RESULTING IN 104.7 PG/ML. ALL RESULTS WERE RELEASED FROM LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK DATA WAS NOT PROVIDED. CALIBRATION PASSED ON 01MAR2026 USING REAGENT LOT 538343 CALIBRATOR LOT 538891. QUALITY CONTROL PASSED WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. PATIENT SAMPLE TYPE WAS LAVENDER EDTA TUBE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24713208 ↗
• InjuryFeb 12, 2025High Test Results; High Test Results

  ON (B)(6) 2025, THE CUSTOMER REPORTED ERRONEOUS ELEVATED ACCESS BNP (ACCESS B-TYPE NATRIURETIC PEPTIDE, PART NUMBER 98200, LOT NUMBER 439890) WERE GENERATED ON THE CUSTOMER¿S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (PART NUMBER A71456, SERIAL NUMBER (B)(6) FOR ONE PATIENT. THE PATIENT¿S INITIAL SAMPLE GENERATED AN ELEVATED RESULT OF 774 PMOL/L ON (B)(6) 2025. THE PATIENT WAS REPORTED TO BE ADMITTED TO THE HOSPITAL WHERE ADDITIONAL TESTING WAS PERFORMED AND DID NOT SHOW ANY ABNORMALITY. THE ADDITIONAL TESTING PERFORMED IS NOT KNOWN AND WAS VERBALLY STATED TO BE ¿AN ECHO AND A CARDIOTHORACIC SCAN¿. THERE WAS NO FURTHER REPORT OF INJURY OF AFFECT TO THE PATIENT. AN ADDITIONAL SAMPLE WAS COLLECTED FROM THE PATIENT AND PRODUCED A RESULT OF 9 PMOL/L ON (B)(6) 2025. THE ORIGINAL SAMPLE WAS RE-RUN, ALTHOUGH PAST THE RECOMMENDED STABILITY) AND PRODUCED A RESULT OF 8 PMOL/L ON (B)(6) 2025. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK PASSED ON (B)(6) 2025. CALIBRATION PASSED ON (B)(6) 2024 WITH REAGENT LOT 439890 AND CALIBRATOR LOT 439218. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO OTHER PA

  Patient problems: Insufficient Information

  MAUDE report 21365885 ↗