Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Reported: September 18, 2024 Initiated: July 29, 2024 #Z-3063-2024
Product Description
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1,164 units (229 US, 935 OUS)
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1,164 units (229 US, 935 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-3063-2024.
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