FDA-Device2018-06-06Class II
Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Hazard
Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples.
Sold states
US Nationwide Distribution
Affected count
N/A
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2018More Siemens Healthcare Diagnostics, Inc. recalls
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