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Access CK-MB 386371Recalls & reported problems

Beckman Coulter, Inc. · The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. · Class 2

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 15099590232368), received between Oct 27, 2016 and Oct 27, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 27, 2016Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED OBTAINING A NON-REPRODUCIBLE CREATINE KINASE, ISOENZYME MB (ACCESS CK-MB) RESULTS GENERATED FROM THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) FOR A PATIENT SAMPLE. ON (B)(6) 2016, AN ELEVATED ACCESS CK-MB RESULT OF 46.848 NG/ML WAS GENERATED. THE SAME SAMPLE WAS REPEATED AND LOWER RESULTS OF 2.456 NG/ML AND 2.046 NG/ML WERE OBTAINED. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTS OF PATIENT INJURIES OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. MDR 2122870-2016-00507 WILL ADDRESS THE TROPONIN I (ACCESS ACCUTNI+3) RESULTS OBTAINED ON (B)(6) 2016 FOR THIS SAME PATIENT. SYSTEM PARAMETERS INCLUDING QUALITY CONTROLS (QCS) AND SYSTEM CHECKS WERE RECOVERING WITHIN ASSAY AND SYSTEM PARAMETERS. CALIBRATION DATA WAS NOT PROVIDED FOR REVIEW. THE SAMPLES WERE COLLECTED IN A 13X100 MM LITHIUM HEPARIN TUBE THAT WAS CENTRIFUGED AT 3000 REVOLUTIONS PER MINUTE (RPM) FOR 5 MINUTES AT ROOM TEMPERATURE. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE ANALYZER'S PERFORMANCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6060677 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.