ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Summary
The FDA issued a Class II for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Num by Siemens Healthcare Diagnostics, Inc.. Reason: The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents..
Details
Source
Device Recall
External ID
Z-3064-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Lot/Code Info: Siemens Material Number: 11319151; UDI-DI: 00630414279176; Lot number: 140
Quantity Affected: 143 units (17 US, 126 OUS)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-29
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3064-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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