Siemens Healthcare Diagnostics, Inc. Recall 95112
Description: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Siemens Healthcare Diagnostics, Inc. Recall 95112 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3063-2024 |
| Event ID | 95112 |
| Event Description | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 |
| Product Type | Devices |
| 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. |
| Quantity | 1,164 units (229 US, 935 OUS) |
| Recall 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. |
| Device Classification | 20240918 |
| Device Code Info | Siemens Material Number: 11097543; UDI-DI: 00630414279206; Lot number: 130414 |
| Center Classification Date | 20240906 |
| Recall Initiation Date | 20240729 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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