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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 Controlssee related information
Date Initiated by FirmMarch 04, 2005
Date PostedMarch 29, 2005
Recall Status1 Terminated 3 on September 29, 2005
Recall NumberZ-0660-05
Recall Event ID 31342
PMA NumberP780012S007 
Product Classification Hepatitis A Test (Antibody And Igm Antibody) - Product Code LOL
ProductIMx HAVAB Controls In Vitro Test
Code Information Lot # 21059Q100 Expiration Date: May 20, 2005
FEI Number 2623532
Recalling Firm/
Manufacturer		 Abbott Health Products, Inc.
Hwy 2 Km 58.0
Barceloneta PR 00617
For Additional Information ContactNydia 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
ActionAbbott 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 Commerce373 Kits
DistributionThe 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 CycleTPLC 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 DatabasePMAs with Product Code = LOL
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