FDA-Device2013-11-13Class II

Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

Siemens Healthcare Diagnostics, Inc.
Hazard

Imprecision with certain lots

Sold states
Worldwide Distribution - USA (nationwide) and Mexico.
Affected count
4963
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0181-2014

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