—#111800

Product

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

FDA product code: DLZ — Enzyme Immunoassay, Phenobarbital
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K011528, K913190
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

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.

Timeline

Recall initiated: 2012-07-30
Posted by FDA: 2012-10-10
Terminated: 2014-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111800. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.