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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Diagnostics ReagentPhenobarbital for ARCHITECT cSystems & AEROSET System

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  Class 2 Device Recall Abbott Diagnostics ReagentPhenobarbital for ARCHITECT cSystems & AEROSET System see related information
Date Initiated by Firm September 26, 2006
Date Posted January 09, 2007
Recall Status1 Terminated 3 on June 14, 2011
Recall Number Z-0454-2007
Recall Event ID 36821
510(K)Number K993031  
Product Classification Phenobarbital Reagent - Product Code DLZ
Product Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
Code Information 39074HW00 (exp. 9/30/06), 41008HW00 (exp. 10/31/06), 42063HW00 (exp. 12/31/06)
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Irene Powers
847-937-1998
Manufacturer Reason
for Recall		 Erratic elevated results and or the inability to calibrate due to imprecision.
FDA Determined
Cause 2		 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 (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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DLZ and Original Applicant = SYVA CO.
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