Siemens Dimension Vista Estradiol Test Recalled Due to Interference
Siemens is recalling Dimension Vista Estradiol tests because the drug fulvestrant may cause falsely elevated 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 is classified as FDA Class II, and the hazard involves a risk of harm (misdiagnosis due to falsely elevated results) where specific injury reports are not detailed in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,945 units of the Dimension Vista LOCI Estradiol Test (Catalog Number: K6463, SMN: 10489099). The recall covers all lots of the product, which was distributed worldwide and across the United States.
The recall was initiated because the drug fulvestrant (Faslodex) may cause falsely elevated estradiol results when using this in vitro diagnostic test. The test is used for the quantitative measurement of estradiol in human serum and plasma to diagnose hormonal sexual disorders and assess placental function.
Healthcare facilities and laboratories should stop using the affected test kits and contact Siemens Healthcare Diagnostics for further instructions on returns or replacements.
The recalled product
- Product
- Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 1,945
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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