Recall Z-0454-2007 ยท DLZ Enzyme Immunoassay, Phenobarbital
Abbott Laboratories Inc.
Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
| Date | Jan 9, 2007 (initiated Sep 26, 2006) |
| Status | Terminated |
| Reason | Erratic elevated results and or the inability to calibrate due to imprecision. |
| Root cause | Other |
| Action | Abbott sent out a product recall letter on 9/26, 2006, to all consignees that received lot numbers 39074HW00, 41008HW00 and 42063HW00. The letter states that the firm has identified a Phenobarbital performance issue that is demonstrated by erratic elevated results and/or the inability to calibrate due to imprecision. Until the cause of this issue is identified, they have discontinued shipment of Phenobarbital reagent. It will be necessary to identity an alternate means for Phenobarbital testing during this time. AXSYM and TDxITDxFLx Phenobarbital are available as alternate testing options (co |
| Quantity | Worldwide: Lot #41008HW00 - 162 kits; Lot #42063HW00 - 136 kits; Lot #39074HW00 - 150 Kits |
| Distribution | Worldwide distribution ---- USA and countries of of Canada, Chile, Germany, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993031 | ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 Syva Co., Jan 27, 2000 |