Dimension® Flex® reagent cartridge EZCR 10471520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768030512), received between Sep 30, 2020 and Sep 30, 2020 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K073055); 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. Dec 18, 2019Class IITerminated

   There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

   Z-1232-2020 · 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.

• MalfunctionSep 30, 2020Low Test Results; Low Test Results

  SIEMENS INVESTIGATED THE IMPACT OF THE ETAMSYLATE DRUG ON THE DIMENSION ENZYMATIC CREATININE (EZCR) ASSAY. SIEMENS PROCESSED SAMPLES AT VARYING CONCENTRATIONS (1.50 MG/DL, 3.00 MG/DL, 4.50 MG/DL, AND 6.00 MG/DL) OF ETAMSYLATE FOR EZCR AND COMPARED THESE RESULTS WITH A SAMPLE WITH NO ETAMSYLATE. SIEMENS OBSERVED THAT THE BIAS WAS GREATEST FOR THE SAMPLE WITH THE ETAMSYLATE CONCENTRATION OF 6.00 MG/DL. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE BIAS OBSERVED IN EZCR RESULTS. ETAMSYLATE (DICYNONE) IS NOT LISTED AS AN INTERFERING SUBSTANCE IN THE DIMENSION ENZYMATIC CREATININE (EZCR) INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10609401 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073055. One submission often covers many models, so check the product and lot details in each record.

• Z-2284-2020 · May 4, 2020 · Terminated
  Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, pla
• Z-1660-2016 · Mar 17, 2016 · Terminated
  Dimension Assays: ENZYMATIC CREATININE
• Z-2177-2011 · Jun 10, 2010 · Terminated
  Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and uri
• Z-0485-2009 · Sep 29, 2008 · Terminated
  Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasm