Dimension® Flex® reagent cartridge SIRO 10464331Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768022111), received between Sep 21, 2017 and Jan 2, 2026 — classified as 3 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K081857); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED SIROLIMUS (SIRO) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON THE ORIGINAL SYSTEM. THE REPROCESSED RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS AND WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED SIROLIMUS (SIRO) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941634 ↗
• MalfunctionApr 26, 2019Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED SIROLIMUS (SIRO) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN (S). A DILUTED SAMPLE FROM THE SAME PATIENT WAS PROCESSED WITH THE SAME INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED SIRO RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8555374 ↗
• MalfunctionSep 21, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED SIROLIMUS RESULT (SIRO) WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS TESTED AT AN ALTERNATE LABORATORY ON A NON-SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED DIMENSION SIRO RESULT ON THE DIMENSION EXL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6883969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081857. One submission often covers many models, so check the product and lot details in each record.

• Z-1670-2018 · Jan 2, 2018 · Terminated
  Dimension Sirolimus (SIRO) Flex reagent cartridge
• Z-1633-2016 · Feb 9, 2016 · Terminated
  Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test