FDA Recall Terminated

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.

Recall: Z-0664-2013 · Initiated December 10, 2012

Recall

Recall Number: Z-0664-2013
Event Number: 63892
Firm: Siemens Healthcare Diagnostics, Inc.
FEI Number: 2517506
Product Code: DLZ
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: December 10, 2012
Posted: January 10, 2013
Terminated: August 27, 2014
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

Description

Reason

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

Action

Siemens sent an "URGENT MEDICAL DEVICE RECALL" notice letter dated November 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and discard any remaining inventory of the affected product. Customers were asked to share the content of the letter with their laboratory director regarding the need to review previous Phenobarbital results, conduct patient follow up and/or repeat testing. For a no charge replacement of remaining inventory customers were instructed to contact Siemens Customer Service Center at 888-588-3916. For questions contact Siemens Technical Solutions Center at 800-227-8994.

Distribution

Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA.

Quantity

1979 cartons