Device product
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.
Z-1946-2018
Product summary
- Event
- Event 79413
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1946-2018
Official wording
Reason: 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.
Code information: Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.