Dimension Vista Flex Reagent Cartridges

• 2 recalls, same reason

  • Terminated Z-1660-2018 FDA Class II ·initiated 29 Jun 2017 ·via K061655, on the same 510(k)
  • Terminated Z-1658-2018 FDA Class II ·initiated 29 Jun 2017 ·via K061655, on the same 510(k)

  Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

• 2 recalls, same reason

  • Terminated Z-1666-2016 FDA Class II ·initiated 17 Mar 2016 ·via K061655, on the same 510(k)
  • Terminated Z-1665-2016 FDA Class II ·initiated 17 Mar 2016 ·via K061655, on the same 510(k)

  Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

• • Terminated Z-0339-2016 FDA Class II ·initiated 30 Sep 2015 ·via K061655, on the same 510(k)

  Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.

• • Terminated Z-2175-2012 FDA Class III ·initiated 17 Jul 2012 ·via K061655, on the same 510(k)

  Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.

• • Terminated Z-1433-2012 FDA Not yet classified ·initiated 17 Feb 2012 ·via K061655, on the same 510(k)

  Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K061655 ↗

FDA Product Code

LDP

Device Class

Class II

Regulation

21 CFR Part 862.3030

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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