Medical device recalls Moderate risk

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

Recall date
July 29, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3064-2024
FDA classification
Class II
Brand / firm
Siemens Healthcare Diagnostics, Inc.
Sold / distributed
Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Egypt, Estonia, Finland, France…

Why it was recalled

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

Get recall alerts

Free email alert whenever Siemens Healthcare Diagnostics, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Siemens Healthcare Diagnostics, Inc.