Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2238-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.

Product Classification:

Class II

Date Initiated: July 15, 2014

Date Posted: August 27, 2014

Recall Number: Z-2238-2014

Event ID: 68848

Reason for Recall:

Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv

Status: Terminated

Product Quantity: 3200

Code Information:

lot RD41041, exp. 10/13/2014

Distribution Pattern:

USA (nationwide) Distribution and Internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated