Reported Jul 25, 2018 · Terminated
Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
Dimension Vista¿ CTNI Sample DiluentKD692SMN# 10445205
- Lot codes and dates
- lot # 17171BD, UDI # (UDI) 008427680158927BDA3418060110445205
- Amount recalled
- 1446
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
This product could cause temporary or reversible health problems — stop using it.
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