Recall Z-0664-2013 ยท DLZ Enzyme Immunoassay, Phenobarbital
Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
| Date | Jan 10, 2013 (initiated Dec 10, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 1979 cartons |
| Distribution | Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA. |
| FDA record | Open on fda.gov |