Date Initiated by Firm |
December 30, 2009 |
Date Posted |
May 19, 2010 |
Recall Status1 |
Terminated 3 on August 31, 2011 |
Recall Number |
Z-1596-2010 |
Recall Event ID |
55165 |
510(K)Number |
K063329
|
Product Classification |
Hepatitis A Test - Product Code LOL
|
Product |
ARCHITECT HAVAB-M Reagent
A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. |
Code Information |
Lot # 76175Q100 exp. date 4/18/10; Lot # 79412Q100 exp. date 7/22/10; Lot # 82584Q100 exp. date 10/20/10. |
Recalling Firm/ Manufacturer |
Abbott Diagnostics International, Ltd. Carr # 2 Km 58.0 Cruce Davila Barceloneta PR 00617
|
For Additional Information Contact |
Saritza Rios 787-846-3500
|
Manufacturer Reason for Recall |
There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.
|
FDA Determined Cause 2 |
Pending |
Action |
Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT. |
Quantity in Commerce |
1,326 |
Distribution |
Nationwide Distribution -- Including Puerto Rico. |
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 = LOL and Original Applicant = ABBOTT LABORATORIES
|