Siemens Dimension Chemistry Wash Recalled for Inaccurate Test Results
Siemens Healthcare Diagnostics is recalling Dimension Chemistry Wash lot RD41041 because it caused accuracy shifts in specific patient and QC test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (inaccurate medical test results) where specific injury or death has not been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,200 units of Dimension Chemistry Wash (RD701), lot RD41041, with an expiration date of 10/13/2014. This product is a wash buffer accessory used in the flex cartridge system for Siemens Dimension RxL and Xpand assays to clean probe sensors between measurements.
The recall was initiated after the company received complaints regarding shifts in the accuracy of quality control and patient sample results. The affected tests include Troponin I, CTNI, LTNI, Free T4, TSH, and N-terminal pro-brain natriuretic peptide (PBNP and LPBN). The product was distributed nationwide in the United States and internationally to Canada.
Users of the affected lot should stop using the product and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 3,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- lot RD41041
- exp. 10/13/2014
Distribution
Distributed nationwide across the United States.
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