Access hsTnI Calibrators C26909Recalls & reported problems
Beckman Coulter, Inc. · The Access hsTnI Calibrators are intended to calibrate the Access hsTnI assay for quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590707194), received between Sep 28, 2026 and Sep 28, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- High Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026High Test Results
On 21 Oct 2025, the customer reported discrepancies between initial hsTNI (high sensitive troponin) results and subsequent ones for two patients when run on their Access 2 analyzer part number (PN) 81600N, serial number (SN) (b)(6).There was no report of injury/delay or death related to the reported issue. There was no a change to patient treatment as a result of the output from the device.One false high result for hsTnI for a pregnant patient, result was expected to be lower than initial result. Customer reported also one false low result for hsTnI on sample that was expected to be of higher result due to patient clinical history. Customer reported that previous result from this patient was 7137 ng/L, patient has a history of high values, and a low value would be very suspicious.Sample 1 patient 1 from (b)(6) 2025, initial result was 9431.09 ng/L. Sample was ran in duplicate in another Access 2 analyzer, SN (b)(6), generating a result of less than 2 ng/L. Another result from second sample run in SN (b)(6) generated a result of < 2.00 ng/L. Sample was ran again on Access SN (b)(6) on (b)(6) 2025 with a result of < 2.00 ng/L. o Sample patient 2 from (b)(6) 2025 generated a result o
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916463 ↗
Other Calibrator, Secondary devices
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
- ARCHITECT 8K28-02Abbott Laboratories · CALIBRATOR, SECONDARY1 recall115 reports
- BioPlex 2200 12000651Bio-Rad Laboratories, Inc. · Calibrator, secondary3 recalls0 reports
- VITROS 8231474Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary3 recalls0 reports
- ARCHITECT 08K2803Abbott GmbH · Calibrator, secondary1 recall93 reports
- ARCHITECT 7K63-25Abbott Ireland · CALIBRATOR, SECONDARY108 reports
- VITROS 8067324Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary2 recalls0 reports
- VITROS 8568040Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, SECONDARY1 recall18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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