Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0030-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital

Product Classification:

Class II

Date Initiated: July 30, 2012

Date Posted: October 17, 2012

Recall Number: Z-0030-2013

Event ID: 62832

Reason for Recall:

Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced. Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be obs

Status: Terminated

Product Quantity: 79,744 cartons

Code Information:

Emit(R) 2000 Phenobarbital Assay (OSR4D229), lots 1151, 1167, 1191, and/or 1212 and Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots D4, D5, D6, and D7

Distribution Pattern:

United States Nationwide Distribution in the states of: CA, FL, KS, MA, MN, MS, NM, NY, NC, OR, PA, TN, TX, UT, VA, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated