Atellica IM CKMB 10995531Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414598581), received between Aug 13, 2021 and Dec 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

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.

• MalfunctionDec 5, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CREATINE KINASE MB (CKMB, LOT 279) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING USING LOT 281. INITIAL ELEVATED RESULTS WERE OBTAINED FOR FOUR (4) PATIENT SAMPLES. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE THEN RETESTED USING AN ALTERNATE REAGENT LOT 281 AND OBTAINED LOWER RESULTS. THE LOWER RESULTS MATCHED THE CLINICAL PICTURES OF THE PATIENTS, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852785 ↗
• MalfunctionAug 13, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED AN ELEVATED ATELLICA IM CREATINE KINASE MB (CKMB) IMMUNOASSAY RESULT COMPARED TO LOW CK ISOENZYME ELECTROPHORESIS RESULTS. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE PHYSICIAN BELIEVES THERE IS AN ABNORMAL HIGH CKMB BY IMMUNOASSAY COMPARED TO CK ISOENZYME BY ELECTROPHORESIS. THE SAMPLE WAS NOT RETESTED USING ATELLICA IM CREATINE KINASE MB (CKMB). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM CKMB RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319406 ↗

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-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-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-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.