Recall Z-0181-2014 ยท DLZ Enzyme Immunoassay, Phenobarbital
Siemens Healthcare Diagnostics, Inc.
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
| Date | Nov 7, 2013 (initiated Aug 30, 2013) |
| Status | Terminated |
| Reason | Imprecision with certain lots |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Urgent Medical Device Recall letter dated August 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product. Siemens will replace unused affected product at no charge. For replacements customers were instructed to incude this information on the Effectiveness Check form included with the letter. The Effectiveness Check form must be returned even if no replacement reagents are needed. The recall letter was to be retained with customers laboratory records and fo |
| Quantity | 4963 |
| Distribution | Worldwide Distribution - USA (nationwide) and Mexico. |
| FDA record | Open on fda.gov |