Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in Recalled by Siemens Healthcare Diagnostics, Inc. Due to Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.
Quantity: 658 units
Why Was This Recalled?
Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples
Where Was This Sold?
This product was distributed to 24 states: CA, CT, DE, FL, GA, IN, IA, KS, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, OH, OK, PA, TN, VA, WA
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report