Access hsTnI B52669Recalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 15099590693183), received between Mar 5, 2019 and Sep 30, 2026 — classified as 85 injuries, 85 malfunctions.

The most frequently reported specific device problem is “High Test Results” (153 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. Nov 18, 2024Open, Classified

   Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.

   Z-0727-2025 · Root cause: Component design/selection · FDA record ↗

2. Aug 9, 2021Open, Classified

   Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.

   Z-0032-2022 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High Test Results

  On 18Sep2024 the customer reported obtaining false high hsTnI (Access High Sensitivity Troponin I, Part Number B52699, lot number 338998) results for one patient involving the laboratory's DxI 600 Access Immunoassay W/Spot B Analyzer (serial number (SN) (b)(6)). There was no injury, death, or delay/change in treatment or diagnosis related to the reported issue and there was no report of harm for a patient, an operator or any other person. Calibration passed with reagent lot 338998 and calibrator lot 338835.Customer reported the plasma separator tube was only partially full.Short samples are known to affect immunoassays by modifying blood to additive ratio. No hardware errors were reported in conjunction with this event. A passing system check was obtained 18SEP2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950477 ↗
• MalfunctionSep 30, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950276 ↗
• MalfunctionSep 30, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950081 ↗
• MalfunctionSep 30, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949835 ↗
• MalfunctionSep 30, 2026High Test Results

  Patient problems: Insufficient Information

  MAUDE report 50949018 ↗
• MalfunctionSep 30, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948079 ↗
• MalfunctionSep 30, 2026High Test Results

  On (b)(6) 2024, the customer reported hsTnI (troponin) high result on first run and normal on second run on one patient result.There was no report of an injury or illness to the patient attributable to the output from the device in this event. There was no report to change to patient care.The hsTnI result initially was 0.124ng/ml on first run and 0.009 ng/ml on second run.Calibration passed on (b)(6)2024 with reagent lot 4399394 and calibrator lot 439283. System check completed on (b)(6)2024 passed. No issues observed with QC Chart and Data Log.The Field Service Engineer (FSE) assisted the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946522 ↗
• MalfunctionSep 30, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946483 ↗
• MalfunctionSep 30, 2026Low Test Results

  The customer reported a questionable high-sensitivity Troponin I (hsTnI) patient result on (b)(6)2025. The patient historically demonstrated hsTnI results of approximately 1,000 ng/L; however, testing on Access 2 analyzer (SN (b)(6) generated an unexpectedly low result of <2 ng/L. Due to the significant discrepancy from the patient's established trend, the customer initiated an investigation and contacted Customer Technical Support (CTS).The customer performed additional testing to evaluate the result. Retesting of the original plasma sample, after mixing and addressing potential fibrin clots, produced results of approximately 500 ng/L and 300 ng/L. Because the original sample volume was limited, a second plasma sample drawn the same day for another test was analyzed on a different Access 2 analyzer (serial number (b)(6) on (b)(6)2025, yielding results of 703 ng/L and 336 ng/L. On (b)(6)2025, dilution studies performed using the second sample generated results ranging from approximately 1,076 ng/L to 1,210 ng/L. Retesting of the second sample on both analyzers produced comparable results that aligned with the patient's historical hsTnI values, demonstrating that the initial low res

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945419 ↗
• MalfunctionSep 30, 2026High Test Results

  The customer reported ACCESS hsTNI 2X50 DET (Part Number B52699, Lot Number 439629) result was 4.1904 ng/ml, which was higher than the reference range (<0.0330) on their UNICEL DXI 800 ACCESS IMMUNO ANALY (Product Number 973100, Serial: (b)(6). The problem sample was retested on a Mindray platform with a result of <0.002 ng/ml, consistent with the patient's clinical presentation.There was no injury, death, or delay/change in treatment or diagnosis related to the reported issue and there was no report of harm for a patient, an operator or any other person. System performance indicators such as calibration and quality control (QC) were not provided for review.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944315 ↗
• MalfunctionSep 30, 2026Imprecise or Erratic Results

  The customer reported an erroneous Troponin I high sensitivity (TnIhs) patient result of 0.43 ng/mL, which was repeated 3 hours later on the original sample and found to be <0.02 ng/mL, on their ACCESS 2 IMMUNOASSAY ANALYZER (Product Number 81600N, Serial Number (b)(6). The assay/reagent product ACCESS hsTNI 2X50 DET (Product Number B52699, Lot Number 439627). All other re-draws were negative. The sample was a short sample, moderately hemolyzed, run in a sample cup in the correct rack, collected in lithium heparin gel tubes, and centrifuged for 5 minutes at 3500 RPM. There was no injury, death, or delay/change in treatment or diagnosis related to the reported issue and there was no report of harm for a patient, an operator or any other person. System performance indicators such as calibration and quality control (QC) were not provided for review. Per verbal report, the customer stated that maintenance was up to date, system checks were passing, controls were in range, and no issues were reported with other assays.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944115 ↗
• MalfunctionSep 30, 2026High Test Results

  The customer reported quality control (QC) failures and erroneous patient results for Access High Sensitivity Troponin I (hsTnI), PN# B52699, Lot# 440451, on a DxI 600 Access Immunoassay Analyzer, PN# A71460, SN# (b)(6). TAs part of their troubleshooting efforts, the customer reviewed QC performance, investigated the reported results, and contacted technical support for assistance. Instrument and assay performance were evaluated to determine the source of the reported issue. There was no report of an injury or illness to the patient attributable to the output from the device in this event. No change to any patient¿s treatment is reported.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50942145 ↗
• MalfunctionSep 30, 2026High Test Results

  The customer reported discrepant patient results for Access High Sensitivity Troponin I (PN# B52699, Lot# 440297) generated on an Access 2 Immunoassay Analyzer (PN# 81600N, (b)(6)). A patient sample initially produced an hsTnI result of 334.8 pg/mL. The sample was subsequently reflex tested by the system and generated a result of 10.5 pg/mL. A newly collected patient sample tested approximately four hours later produced a negative result. This report is for Patient#1.There was no report of an injury or illness to the patient attributable to the output from the device in this event. No change to any patient¿s treatment is reported.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50942142 ↗
• MalfunctionSep 30, 2026High Test Results

  The customer reported discrepant patient results for Access High Sensitivity Troponin I (PN# B52699, Lot# 440297) generated on an Access 2 Immunoassay Analyzer (PN# 81600N, SN# (b)(6)). A patient sample initially produced an hsTnI result of 334.8 pg/mL. The sample was subsequently reflex tested by the system and generated a result of 10.5 pg/mL. A newly collected patient sample tested approximately four hours later produced a negative result. This report is for Patient#2.There was no report of an injury or illness to the patient attributable to the output from the device in this event. No change to any patient¿s treatment is reported.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50942141 ↗
• MalfunctionSep 29, 2026Imprecise or Erratic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936163 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936158 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932284 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932105 ↗
• MalfunctionSep 29, 2026High Test Results

  On (b)(6)2026 the customer reported questioning elevated hsTnI results for one patient with the Access hsTnI assay (Reagent Part Number B52699 Lot number 672212) on their DxI 600 instrument (Part Number A30260 Serial Number (b)(6)).The customer reported 60-year-old woman with a history of cryoglobulinemia and a non-ST elevation myocardial infarction (NSTEMI) in July is currently experiencing no cardiac complaints, despite presenting with very high troponin levels (around 3000 ng/L).¿ Multiple troponin I measurements between (b)(6) and (b)(6)2026, consistently show elevated levels (ranging from 2726 to 3860 ng/L). Troponin I results from (b)(6) were also elevated (20.7 and 24.9 ng/L), with one measurement being 755 ng/L after shorter cooling and 507 ng/L after longer cooling. The customer expected troponin I levels to normalize after the NSTEMI therefore, the persistently elevated troponin results raised strong suspicion of analytical interference.There was no injury, death, or delay/change in treatment or diagnosis related to the reported issue and there was no report of harm for a patient, an operator or any other person. Per customer¿s statement, there were no clinical consequenc

  Patient problems: Insufficient Information

  MAUDE report 50928125 ↗
• MalfunctionSep 28, 2026Low Test Results

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50922646 ↗
• MalfunctionSep 28, 2026High Test Results

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50921495 ↗
• MalfunctionSep 28, 2026High Test Results

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50919463 ↗
• MalfunctionSep 28, 2026High Test Results

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50919089 ↗
• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917856 ↗
• MalfunctionSep 28, 2026High Test Results

  On (b)(6)2024, the customer reported erroneously elevated hsTnI patient results. There was no report of an injury or illness to the patient attributable to the output from the device in this event. The customer reported the following hsTnI results with two patient samples. Units of measure were not provided: Initial result 729 repeat on same and alternate instrument 8-11 Initial result 83 repeat 8.29 repeated on alternate instrument 6 Three levels of Quality Controls (QC) were passing within the laboratory¿s established ranges The customer reported both samples were lithium heparin and one sample was not a full draw and customer unsure about sample mixing and sample was centrifuged on the line. No hardware errors were reported in conjunction with this event.FSE was dispatched to the customer's site.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916694 ↗