Reported Jul 25, 2018 · Terminated
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
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¿ MULTI 2 SDILKD694SMN# 10483586
- Lot codes and dates
- lot 7CDA79, UDI # (UDI) 008427680324177CDA7918090110483586, exp 2018-09-01; lot # 7DDA70, UDI # (UDI) 008427680324177DDA7018110110483586, exp 2018-11-01
- Amount recalled
- 1195
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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