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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT HAVABM Reagent

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 Class 2 Device Recall ARCHITECT HAVABM Reagentsee related information
Date Initiated by FirmDecember 30, 2009
Date PostedMay 19, 2010
Recall Status1 Terminated 3 on August 31, 2011
Recall NumberZ-1596-2010
Recall Event ID 55165
510(K)NumberK063329 
Product Classification Hepatitis A Test - Product Code LOL
ProductARCHITECT 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.
FEI Number 2623532
Recalling Firm/
Manufacturer		 Abbott Diagnostics International, Ltd.
Carr # 2 Km 58.0
Cruce Davila
Barceloneta PR 00617
For Additional Information ContactSaritza 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
ActionDirect 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 Commerce1,326
DistributionNationwide Distribution -- Including Puerto Rico.
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.
510(K) Database510(K)s with Product Code = LOL
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