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

FDA device recall Z-0030-2013 · posted 2012-10-10 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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 taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DLZ

Quantity affected

79,744 cartons

Distribution

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.

Date initiated

2012-07-30

Date posted

2012-10-10

Date terminated

2014-08-27

Location

Newark, DE

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