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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM Quinidine Standard Calibrators

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  Class 2 Device Recall AxSYM Quinidine Standard Calibrators see related information
Date Initiated by Firm May 31, 2007
Date Posted August 22, 2007
Recall Status1 Terminated 3 on June 10, 2011
Recall Number Z-1185-2007
Recall Event ID 38167
510(K)Number K940682  
Product Classification Quinidine Standard Calibrators - Product Code LGI
Product AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01
Code Information Lot # 44794Q100 Exp. Date: 08/09/2007 and  Lot # 47093Q100 Exp. Date: 10/10/2007
Recalling Firm/
Manufacturer		 Abbott Diagnostic International, Ltd.
30 Bo Cruce Davila
Barceloneta PR 00617-3009
For Additional Information Contact Saritza Rios
787-846-3500
Manufacturer Reason
for Recall		 Controls Out of Range/Specification .
FDA Determined
Cause 2		 Other
Action May 31, 2007, Product Correction Letter to Customers were instructed to: "Revise the expiration date for all lots identified in the customer letter. "Discontinue use of the expired lots, and discard the material according to their laboratory procedures. "An additional option is to use the Abbott Immunoassay Multiconstituent Control (List Number 06E20), manufactured by BIO-RAD.
Quantity in Commerce 267
Distribution Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
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 = LGI and Original Applicant = ABBOTT LABORATORIES
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