FDA recall Z-3064-2024

Siemens Healthcare Diagnostics, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

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, Georgia, Germany, Greece, Hong Kong, Hungary, India, India, Ireland, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E., United Kingdom, Uruguay, Vatikancity.

Key facts

Status
Ongoing
Initiation date
2024-07-29
Report date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3064-2024