Recall Z-0030-2013 ยท DLZ Enzyme Immunoassay, Phenobarbital
Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
| Date | Oct 10, 2012 (initiated Jul 30, 2012) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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 Cente |
| Quantity | 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. |
| FDA record | Open on fda.gov |