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Class 2 Device Recall AxSYM Quinidine Controls |
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Date Initiated by Firm |
May 31, 2007 |
Date Posted |
August 22, 2007 |
Recall Status1 |
Terminated 3 on June 10, 2011 |
Recall Number |
Z-1186-2007 |
Recall Event ID |
38167 |
510(K)Number |
K940682
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Product Classification |
Quinidine Controls - Product Code LGI
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Product |
AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing quinidine prepared in human serum to yield the different concentration ranges-Product List Number 7A73-10 |
Code Information |
Lot # 43273Q100 Exp. Date: 06/23/2007 and Lot # 47028Q100 Exp. Date; 10/14/2007 |
Recalling Firm/ Manufacturer |
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila Barceloneta PR 00617-3009
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For Additional Information Contact |
Saritza Rios 787-846-3500
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Manufacturer Reason for Recall |
Controls Out of Range/Specification .
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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 |
119 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LGI and Original Applicant = ABBOTT LABORATORIES
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