Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-1703-2017

Z-1703-2017 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Newark, DE

FDA device recall Z-1703-2017 was initiated by Siemens Healthcare Diagnostics, Inc. on March 3, 2017 and is designated Class II. Reason for recall: Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential f… The recall status is terminated (terminated July 3, 2018). Affected quantity: 2733 systems.

Recall Details

Product Type
Devices
Report Date
April 5, 2017
Initiation Date
March 3, 2017
Termination Date
July 3, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2733 systems

Product Description

Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.

Reason for Recall

Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result.

Distribution Pattern

Worldwide Distribution - United States Nationwide and Puerto Rico, Canada, Qatar, Republic Korea, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, and Portugal.

Code Information

Device Listing D011374 Serial Number: All serial numbers

Other recalls by Siemens Healthcare Diagnostics, Inc.

  • Z-2890-2026 Class II — Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic (July 6, 2026)
  • Z-2880-2026 Class III — Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catal (June 26, 2026)
  • Z-2881-2026 Class III — Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 (June 26, 2026)
  • Z-2703-2026 Class II — Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. (June 8, 2026)
  • Z-2398-2026 Class II — Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107007 (May 7, 2026)
  • Z-2005-2026 Class II — epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Ma (April 2, 2026)
  • Z-1980-2026 Class II — Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. (March 18, 2026)
  • Z-1657-2026 Class II — Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11 (February 23, 2026)
  • Z-1484-2026 Class II — Atellica CH Urine Albumin (UAlb). Material Number: 11537225 (January 20, 2026)
  • Z-0492-2026 Class II — 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adj (October 6, 2025)

FDA data resources