Elecsys Beta-CrossLaps/serum 09005781190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336171561), received between Jun 14, 2023 and Jun 23, 2025 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS B-CROSSLAPS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: >6 NG/ML (REFERENCE RANGE 0.21-0.44 NG/ML). THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, AND THE SAMPLE WAS MANUALLY DILUTED WITH A LOW-CONCENTRATION SERUM AND REPEATED. THE REPEAT RESULTS WERE AS FOLLOWS: 1ST REPEAT RESULT: >6 NG/ML (TESTED WITH A DILUTION FACTOR OF 1:2). 2ND REPEAT RESULT: 1.94 NG/ML (TESTED WITH A DILUTION FACTOR OF 1:4). 3RD REPEAT RESULT: 0.872 NG/ML (TESTED WITH A DILUTION FACTOR OF 1:8). THE CUSTOMER SUSPECTED AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309715 ↗
• MalfunctionJun 14, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS -CROSSLAPS/SERUM IMMUNOASSAY RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 4 PATIENT SAMPLES. ON (B)(6) 2023, PATIENT 1 HAD AN INITIAL -CROSSLAPS RESULT OF 70.4 PG/ML. THE REPEAT RESULT WAS 521 PG/ML. ON (B)(6) 2023, PATIENT 2 HAD AN INITIAL -CROSSLAPS RESULT OF 63.3 PG/ML. THE REPEAT RESULT WAS 529 PG/ML. ON (B)(6) 2023, PATIENT 3 HAD AN INITIAL -CROSSLAPS RESULT OF 60.6 PG/ML. THE REPEAT RESULT WAS 548 PG/ML. ON (B)(6) 2023, PATIENT 4 HAD AN INITIAL -CROSSLAPS RESULT OF 60.1 PG/ML. THE REPEAT RESULT WAS 624 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17129878 ↗