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U.S. Department of Health and Human Services

Class 3 Device Recall IMx HAVAB Controls

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  Class 3 Device Recall IMx HAVAB Controls see related information
Date Initiated by Firm October 27, 2004
Date Posted November 20, 2004
Recall Status1 Terminated 3 on March 16, 2005
Recall Number Z-0217-05
Recall Event ID 30388
PMA Number P780012S007 
Product Classification Hepatitis A Test (Antibody And Igm Antibody) - Product Code LOL
Product IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control.
Code Information Lot # 18220Q100 Exp. March 02, 2005
Recalling Firm/
Manufacturer		 Abbott Health Products, Inc.
Hwy 2 Km 58.0
Barceloneta PR 00617
For Additional Information Contact Nydia I. Cancel
787-846-3500
Manufacturer Reason
for Recall		 Abbott identified through investigational studies that IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.
FDA Determined
Cause 2		 Other
Action Device recall letters were dated 10/27/2004. Letter was mail to customers asking to destroy and discontinue use of device. On hand inventory information was requested to be forward to Abbott at 1-800-777-0051 (U.S. only).
Quantity in Commerce 397 kits
Distribution The product has been distributed to hospitals, laboratories and other institution including government accounts. Geographic areas of distribution include Puerto Rico, Canada, Germany, Thailand and U.S.A. Government accounts includes: VA Medical Center, Saint Louise, MO; Brecksville VA Hosp. Supp, Brecksville, OH; VA MED CENTER, Phoenix, AZ; Department Veterinary Affair Med., Houston, TX; VA Med., Cincinnati, OH; VA Med Center, Seattle, WA; Truman Mem. VA, Columbia, MO; Dept. Vet. Aff., Shreveport, LA; VA Hosp. Whse., Fresno, CA ; VA Med Center, Omaha, NE ; VA Med. Center, Lexington, KY; VA Med Center, Detroit, MI ; VA Hosp., San Diego, CA ; Naval Hosp., Great Lakes, IL; VA Med. Center, San Francisco, CA.
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.
PMA Database PMAs with Product Code = LOL and Original Applicant = Abbott Laboratories
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