Siemens Dimension Vista Calcium Flex Reagent Cartridge Recalled for Low Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium Flex reagent cartridges because they may produce erroneously low results from specific well sets.
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 is classified as FDA Class II, and the hazard involves a risk of harm (erroneously low diagnostic results) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 6,000 units of the Dimension Vista Calcium Flex reagent cartridge (K1023, SMN # 10445160). The affected product is identified by Lot # 17171BD and has an expiration date of 06-20-2018. The product is an in vitro diagnostic test used for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
The recall was initiated because the product may produce erroneously low results from specific well sets. This defect could lead to inaccurate diagnostic measurements for patients.
The affected units were distributed nationwide in the United States and to several international countries, including Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, and Switzerland. Users of the Dimension Vista System should check their inventory for the specific lot number and stop using the affected cartridges.
The recalled product
- Product
- Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 6,000
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 (2)
- Lot # 17171BD
- UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018
Distribution
Distributed nationwide across the United States.
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