Siemens Vista Drug 4 Calibrator Recalled for Low Bias
Siemens is recalling Vista Drug 4 Calibrators because they cause low digoxin test results, potentially affecting patient care.
What this means for you
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 that produces inaccurate diagnostic results (15% low bias), which poses a risk of harm to patients through incorrect treatment decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,638 units of the Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The recall involves specific lots of the calibrator used for in vitro diagnostic testing.
The recall was initiated after Siemens confirmed complaints of low quality control and patient recovery results when using the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge. Internal testing indicated an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL when calibrating with the affected lots.
The affected products were distributed to laboratories in 44 states, the District of Columbia, and Puerto Rico. Users should stop using the affected calibrators and contact Siemens for instructions on returning the product.
The recalled product
- Product
- Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,638
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 (7)
- Catalog Number KC460
- SMN 10472284
- lot 2KD052
- exp 5/1/14 and Catalog Number KC460A
- SMN 10476471
- lot 2KD053
- exp 5/1/14.
Distribution
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