Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is 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
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Quantity: 1,004 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