Atellica IM CKMB 10995530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414598574), received between Nov 27, 2019 and Apr 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K962126); they may or may not involve this specific model.

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.

• MalfunctionApr 23, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN INITIAL ELEVATED ATELLICA IM CREATINE KINASE MB (CKMB) RESULT ON A SERUM SAMPLE WHICH DID NOT FIT WITH THE CLINICAL PICTURE OF THE PATIENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN AND WAS RETESTED ON THE SAME DAY. THE RETEST RESULTS WERE LOWER AND CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890517 ↗
• MalfunctionNov 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER OBSERVED AN ELEVATED RESULT WITH ATELLICA IM 1300 CREATINE KINASE MB (CKMB) COMPARED TO A RESULT GENERATED WITH A DIFFERENT LOT OF ATELLICA IM CKMB CALIBRATORS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE CONSEQUENCES DUE TO THE ELEVATED RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9385331 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962126. One submission often covers many models, so check the product and lot details in each record.

• Z-0115-2019 · Jul 24, 2018 · Terminated
  ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be
• Z-0117-2019 · Jul 24, 2018 · Terminated
  Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be r
• Z-0114-2019 · Jul 24, 2018 · Terminated
  ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
• Z-0116-2019 · Jul 24, 2018 · Terminated
  Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly a
• Z-0113-2019 · Jul 24, 2018 · Terminated
  ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.