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U.S. Department of Health and Human Services

Class 2 Device Recall Appraise A1C Test Pak Kit (Alere

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 Class 2 Device Recall Appraise A1C Test Pak Kit (Aleresee related information
Date Initiated by FirmJanuary 09, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on December 26, 2012
Recall NumberZ-0556-2012
Recall Event ID 57863
510(K)NumberK990899 
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
ProductAppraise A1C Test Pak Kit (Alere), Product K7300, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
Code Information All kits containing Triad alcohol prep pads
Recalling Firm/
Manufacturer		 Heritage Labs International LLC
560 N Rogers Rd
Olathe KS 66062-1211
For Additional Information ContactVicki Harbarger
913-764-1045
Manufacturer Reason
for Recall		Kits contain recalled Triad alcohol pads
FDA Determined
Cause 2		Material/Component Contamination
ActionHeritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any questions call (888)764-4120.
Quantity in Commerce1,883 kits
DistributionWorldwide Distribution - USA (nationwide) and Germany
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 = LCP
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