Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
FDA device recall Z-0454-2007 · posted 2007-01-09 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Inc.
- Reason for recall
- Erratic elevated results and or the inability to calibrate due to imprecision.
- Action taken
- 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 (consignee may contact the local sales person or Customer Service). Consignees also advised if they forwarded any of the Clinical Chemistry Phenobarbital lots listed above to another laboratory to provide a copy of the letter to their customer. If there are questions, they are advised to call Customer Service (US consignee) or local sales person (foreign consignee). Letter advises if user currently using or have inventory of lot number 39074HW00, expiration 9/30/06, to run two levels of quality control (QC) every 6 hours and be alert to QC trends. For those using or have inventory of lot numbers 41008HW00 & 42063HW00, they are advised to discontinue use of these lots and destroy them following laboratory procedures. Abbott will provide reimbursement for the destroyed kits. A customer reply form is provided.
- Root cause
- Other
- Status
- Terminated
- Product code
- DLZ
- Quantity affected
- 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
- Date initiated
- 2006-09-26
- Date posted
- 2007-01-09
- Date terminated
- 2011-06-14
- Location
- South Pasadena, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (K993031) | Syva Co. | 2000-01-27 |