Siemens Stratus CS Acute Care D-dimer Calibrator Recall
Siemens is recalling specific lots of D-dimer Calibrators that may cause instrument calibration errors.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and the issue is limited to instrument calibration errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 786 cartons of Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002. The affected lots were distributed nationwide in the United States.
The recall was initiated because the calibrators may exhibit SLOPE or CALCV error messages, which indicate calibration failures. These errors can affect the performance of the Stratus(R) CS Acute Care(TM) D-dimer method.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens for further instructions.
The recalled product
- Product
- Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R)…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 786
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 (3)
- DDMR CalPak lots 502058002
- exp 2012/11/23 and 501318002
- exp 2012/08/10
Distribution
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