Devices

Device Recall ADVIA Chemistry (Syva Onboard) Theophylline_2 reagent

Model / Serial
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 Syva¿ EMIT¿ 2000 Theophylline - kit lot G3
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
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
Product Description
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.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall ADVIA Chemistry (Syva Onboard) Theophylline_2 reagent

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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