Device Recall Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) 의 리콜

Recall

63892

Class 2

Z-0664-2013

2012-12-10

2013-01-10

Terminated

United States

2014-08-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114962

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.

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.