Siemens Dimension Chemistry Wash Recalled for Result Shifts
Siemens is recalling Dimension Chemistry Wash lots that may cause shifts in QC and patient sample results for specific tests.
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 involves a medical device where the hazard is inaccurate test results (result shifts) without reported injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 17,719 units of Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052. The product is used in the Dimension(R) system with the heterogeneous module. The recall covers lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461, which shipped between December 12, 2012, and March 22, 2013.
The recall was initiated after Siemens received complaints that the Chemistry Wash caused quality control and patient sample result shifts on specific tests, including CTN1, LTN1, FT4, TSH, PBNP, and LPBN. An internal investigation confirmed that these shifts can occur in specific scenarios involving the affected lots.
The affected product was distributed nationwide in the United States and overseas. Healthcare facilities and users of the Dimension(R) system should stop using the affected lots and contact Siemens for further instructions.
The recalled product
- Product
- Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 17,719
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 (10)
- Lot numbers RD23031
- exp 2013-04-29
- RD23111
- exp 2013-05-07
- RD23241
- exp 2013-05-19
- RD23311
- exp 2013-06-04
- and RD23461
- exp 2013-06-11
Distribution
Distributed nationwide across the United States.
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