Siemens Dimension Vista MULTI 1 SDIL Diluent Recall for Defective Septum
Siemens is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent due to a potential defect in the vial cap septum that may cause 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 defect that can lead to erroneous test results, which is a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent (KD693, SMN# 10469971, Lot # 7BDA81). The recall was initiated because the diluent vial caps may have an incomplete slit on the septum.
This defect has the potential to cause erroneously elevated test results if a sample is autodiluted onboard the system. The issue occurs because a defective septum may result in a reduced volume of diluent being pipetted from the vial.
The affected products were distributed to all 50 US states, DC, Guam, Saipan, and the Virgin Islands, as well as to numerous international locations including Australia, Canada, and various European and Asian countries. Users should stop using the affected diluent and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 197
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 # 7BDA81
- UDI # (UDI) 008427680303147BDA8118030110469971
Distribution
Part of a larger recall action
This product is one of 3 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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