FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
- Recall number
- Z-3064-2024
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
- Status
- Open, Classified
- Initiated
- 2024-07-29
- Posted
- 2024-09-06
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- On July 29, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Impact to Results Erroneously depressed or elevated urine protein or cerebrospinal fluid patient results may occur. Siemens investigation revealed a positive bias of up to 52% (at 27.3 mg/dL (273 mg/L); up to 19% at 68.7 mg/dL (687 mg/L)). However, analyte recovery decreases rapidly after opening a reagent pack and a negative bias of up to -35% was observed at 24 hours (at 27 mg/dL (270 mg/L); up to -9% at 67 mg/dL (670 mg/L)). Results of this assay would be interpreted in conjunction with the patient s medical history, clinical presentation, and other findings. Customer Actions: 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Discontinue use of and discard the kit lot listed in the table above (Products Section). 3. Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. 4. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
- Quantity
- 143 units (17 US, 126 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.
- Lot, serial or model codes
- Siemens Material Number: 11319151; UDI-DI: 00630414279176; Lot number: 140
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CEK
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28