Medical Device Recall: Z-0030-2013

FDA Recalls dataset · Firm: Siemens Healthcare Diagnostics, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2012-07-30 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0030-2013.

Recall Res Number
Z-0030-2013
Recalling Firm / Manufacturer
Siemens Healthcare Diagnostics, Inc.
FEI Number
2517506
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2012-07-30
Date Posted
2012-10-10
Date Terminated
2014-08-27
Product Code
DLZ
Event Number
62832
Product Quantity
79,744 cartons
Product Description Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
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
Action Details Siemens sent an Urgent Field Safety notice letter dated July 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 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 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.
Code Information / Serial Numbers 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

Related Establishments / Registrations

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