Siemens Dimension Vista Calcium Reagent Cartridge Recall for Erroneous Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium reagent cartridges that may produce inaccurate test results.
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 involves a medical device that may produce erroneous diagnostic results, which poses a risk of harm to patients through misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 5,991 units of the Dimension Vista Calcium (CA) Flex reagent cartridge, Batch Number 16060BB. The recall was initiated because the company determined that the affected lot may produce erroneously low or high results from specific well sets.
The affected product was distributed nationwide in the United States and in Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain. The agency has classified this recall as Class II.
Healthcare facilities and users should stop using the affected reagent cartridges and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 5,991
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 (1)
- Device Listing No: D011443 Batch Number 16060BB
Distribution
Distributed nationwide across the United States.
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