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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Clinical Chemistry Albumin BCG (AlbG)

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  Class 2 Device Recall Abbott Clinical Chemistry Albumin BCG (AlbG) see related information
Date Initiated by Firm March 10, 2010
Date Posted April 18, 2012
Recall Status1 Terminated 3 on April 18, 2012
Recall Number Z-1434-2012
Recall Event ID 55440
510(K)Number K981758  
Product Classification Bromcresol green dye-binding, albumin - Product Code CIX
Product Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21
Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX

The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
Code Information Lot Numbers: 77056HW00; 80051HW00; 83030HW00 Exp dates: 04/15/2011, 07/15/2011, and 10/10/2011, respectively.
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact
626-440-0705
Manufacturer Reason
for Recall		 Observed particulate matter in some reagent cartridges.
FDA Determined
Cause 2		 Material/Component Contamination
Action Abbott Laboratories sent a Product Recall notification letter dated March 10, 2010, to all affected customers. The notification letter contained an explanation, patient impact, neccassary actions, and contact information. Customers were instructed to determine if they currently have any of the affected product in their inventory. Discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures. Completed the enclosed Customer Reply Form. If customers forwarded any of the affected product they should provide a copy of the notification letter to their customers. For any questions customers should call Customer Service at 1-877-422-2688. For questions regarding this recall call 626-440-0705.
Quantity in Commerce 2718 (U.S. 652)
Distribution US nationwide and internationally to Germany, Hong Kong, Australia, New Zealand, Trinidad/Tobago, and Jamaica. No dsitribution of Canada or Mexica.
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 = CIX and Original Applicant = ABBOTT LABORATORIES
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