Device product
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.
Z-2298-2016
Product summary
- Event
- Event 74524
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,004 units
- Official record key
device-enforcement:Z-2298-2016
Official wording
Reason: 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.
Code information: Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 Syva¿ EMIT¿ 2000 Theophylline - kit lot G3
Distribution pattern: Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA
Derived failure modes
-
Unknown
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.