Z-2238-2014Class II

Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens...

Name: Z-2238-2014 Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-07-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-07-15 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2014-07-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2238-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-15
Posted: 2014-08-15
Terminated: 2015-08-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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 code: JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
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
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Siemens sent an Urgent Medical Device Recall letter dated July 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer: 1. Immediately discontinue use and discard all inventory of Chemistry Wash lot RD41041. If this lot was never in use on the instrument, no further action is needed. If this lot has been in use, continue with steps 2 through 5. 2. Place an alternate lot of Chemistry Wash on the Dimension system. 3. Prime the new bottle of Chemistry Wash 30 times. 4. Recalibrate the CTNI, LTNI, TSH, FT4, PBNP and/or LPBN assays using the alternate lot of Chemistry Wash on board. 5. For the listed assays, process Quality Control every 8 hours. Actions to be taken by Siemens: Your Customer Service Engineer will be making a visit to decontaminate the system if you have used lot RD41041. This process will take approximately two hours. Once decontamination has been completed, process and evaluate quality control. Resume routine QC testing frequency according to your standard laboratory practice. Siemens is shipping replacement product at no charge for all orders filled with lot RD41041. If you have questions about your replacement shipment, please contact Customer Service at (888) 588-3916. Please complete the attached form and fax it to (302) 631-8467 to indicate that you have received this information. Please retain this letter with your laboratory records. Please forward this letter to anyone to whom you may have provided this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 3200
Distribution: USA (nationwide) Distribution and Internationally to Canada.
Product codes and lots: lot RD41041, exp. 10/13/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2238-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2238-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15

Product code JMG

K963498Class IIFerr Flex Reagent CartridgeDade Chemistry Systems, Inc. / cleared 1997-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)