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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 March 04, 2005
Date Posted March 29, 2005
Recall Status1 Terminated 3 on September 29, 2005
Recall Number Z-0660-05
Recall Event ID 31342
PMA Number P780012S007 
Product Classification Hepatitis A Test (Antibody And Igm Antibody) - Product Code LOL
Product IMx HAVAB Controls In Vitro Test
Code Information Lot # 21059Q100 Expiration Date: May 20, 2005
Recalling Firm/
Manufacturer		 Abbott Health Products, Inc.
Hwy 2 Km 58.0
Barceloneta PR 00617
For Additional Information Contact Nydia I. Cancell
787-846-3500 Ext. 7350
Manufacturer Reason
for Recall		 Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
FDA Determined
Cause 2		 Other
Action Abbott identified through investigational studies that IMx HAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package insert. If a control value is out of the specified range, the assay run is invalid and assay recalibration may be indicated. If the control values are within range as specified in the package insert, the assay run is valid and the patient results are not impacted.
Quantity in Commerce 373 Kits
Distribution The recalled IMx HAVAB Controls were distributed nationwide in the United Stated, including Puerto Rico and internationally were distributed to Canada, Peru, Germany, Japan, Australia, and Singapore. There are US Government accounts.
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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