Siemens Dimension Vista CA 15-3 Diagnostic Cartridges Recalled for Measurement Bias
Siemens Healthcare Diagnostics is recalling Dimension Vista CA 15-3 Flex reagent cartridges because the diagnostic test can produce inaccurate results, reading 26–33% lower than actual values, potentially delaying appropriate patient treatment decisions.
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: This is an FDA Class II recall of a diagnostic device with no reported illnesses or injuries. The hazard is theoretical—a potential risk of delayed treatment decisions—meeting the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista LOCI CA 15-3 Flex reagent cartridges, a diagnostic device used to measure CA 15-3 levels in patient samples. A total of 129 units were distributed in the United States and 159 units in other countries including Canada, Austria, France, Germany, Italy, and Switzerland.
The recalled cartridges can produce inaccurate test results. Patient sample measurements show a negative bias, with results reading 26% to 33% lower than actual values. This inaccuracy creates a potential risk of delayed appropriate treatment and management decisions.
Affected lots and expiration dates are as follows: lot 21340BB (expiration 2022-12-06), lot 22049BC (expiration 2023-02-18), and lot 22112BF (expiration 2023-04-20).
The recalled product
- Product
- Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- negative-bias
- treatment-delay-risk
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 (4)
- UDI: 0084276802852621340BB22120610464344840
- 0084276802852622049BC23021810464344840
- lot 22049BC (corrected lot number 9/8/2022) Exp Date: 2023-02-18
- lot 22112BF Exp Date: 2023-04-20.
Distribution
Distributed nationwide across the United States.
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