|
Class 3 Device Recall IMx HAVAB Controls |
|
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
|
|
|
|