FDAClass IIAugust 27, 2014

Siemens Dimension Chemistry Wash recall

Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash…

Why was Siemens Dimension Chemistry Wash recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot RD41041, exp. 10/13/2014

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…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
3200
Distribution
USA (nationwide) Distribution and Internationally to Canada.
Recall date
August 27, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls