Dimension Cardiac Troponin-I Flex reagent cartridge 10444905Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768013836), received between Aug 15, 2022 and Aug 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K010313); 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.

Recalls naming this device

1. May 18, 2022Class IITerminated

   Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 g/L], may lead to inappropriate intervention for myocardial infarction

   Z-1341-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING AN INTERNAL INVESTIGATION, SIEMENS REAGENT MANUFACTURING TECHNICAL OPERATIONS OBSERVED A BIAS IN RESULT RECOVERIES WITH CARDIAC TROPONIN-I (CTNI) LOT BA3088 ON A DIMENSION® RXL MAX® INTEGRATED CHEMISTRY SYSTEM. THE ISSUE WAS IDENTIFIED IN AN INTERNAL STUDY. NO PATIENT RESULTS WERE REPORTED TO PHYSICIANS. THERE HAS BEEN NO REPORTED CUSTOMER IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225933 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010313. One submission often covers many models, so check the product and lot details in each record.

• Z-1731-2009 · Apr 8, 2008 · Terminated
  Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro d
• Z-0858-2010 · Mar 2, 2007 · Terminated
  Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521. Intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized