—#209476

Product

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

FDA product code: CEK — Biuret (Colorimetric), Total Protein
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: Siemens Material Number: 11097543; UDI-DI: 00630414279206; Lot number: 130414

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-07-29
Posted by FDA: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209476. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.