FDAFDA · Food and drugs·Recall number Z-0664-2013
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
Published January 16, 2013 · Recall initiated: December 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA.
- Lot
- Emit(R) 2000 Phenobarbital Assay (OSR4D229) lots 1237 and 1264 and/or Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots E1, E2, and E3.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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