Siemens Dimension IRON Calibrator Recalled for Calibration Slope Issues
Siemens Healthcare Diagnostics is recalling Dimension IRON Calibrators because some lots produced calibration results outside acceptable ranges.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. This in vitro diagnostic product is intended to calibrate the Iron method for the Dimension(R) clinical chemistry system. The recall involves 5,999 units distributed nationwide.
The recall was initiated after the manufacturer received complaints that IRON calibrations were outside of acceptable calibration slope (m) values (0.97 - 1.03) when using specific calibrator lots. The affected lots include 2DN060 (exp 2013-10-01) and 2FN063 (exp 2013-12-01). The manufacturer notes that lots 2GN068 (exp 2014-01-01) and 2JN073 (exp 2014-03-01) may also be impacted, although no complaints have been received for these specific lots.
This is an FDA Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences. Users should check their inventory for the listed material and lot numbers and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 5,999
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 (8)
- Siemens material number 10445010 -- and lot numbers 2DN060
- exp 2013-10-01
- 2FN063
- exp 2013-12-01
- 2GN068
- exp 2014-01-01
- and 2JN073
- exp 2014-03-01.
Distribution
Distributed nationwide across the United States.
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