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U.S. Department of Health and Human Services

Class 2 Device Recall CD4NOW Gold Reagent Pack

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  Class 2 Device Recall CD4NOW Gold Reagent Pack see related information
Date Initiated by Firm November 02, 2011
Date Posted March 08, 2012
Recall Status1 Terminated 3 on April 26, 2012
Recall Number Z-1193-2012
Recall Event ID 61092
510(K)Number K072869  
Product Classification Counter, differential cell - Product Code GKZ
Product PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack,
Part Number :30034
In Vitro Diagnostic : Assay reagent intended for use on the PointCare NOW In Vitro Diagnostics Instrument to provide CD4 positive lymphocytes cell count
Code Information Lot Numbers:KG13230, KG13231, KG21520 and KG21521
Recalling Firm/
Manufacturer		 Pointcare Technologies, Inc.
257 Simarano Dr
Marlborough MA 01752-3070
For Additional Information Contact Same
508-281-6925
Manufacturer Reason
for Recall		 Stability not assured at labeled temperature 2-42¿C
FDA Determined
Cause 2		 Storage
Action The firm, PointCare, issued a "Customer Service Advisory (CSA-00016)" dated November 2, 2011 to its customers to inform them of the new storage requirements of 2-30¿C as opposed to the previously claimed 2-42¿C. The letter describes the product, problem and action to be taken. The customers were instructed to correct the labeling on any Gold Reagent Packs and Gold Reagent and ensure that the Gold Reagent Packs and Gold Reagent they currently have in stock is stored within the 2-30¿C storage range. Future lots will be labeled with the updated storage temperatures. A member of our customer support team will provide additional information relative to this advisory. Should you have any questions or require further assistance, you may email us at customersupport@pointcare.net or call our offices directly at 1-508-281-6925.
Quantity in Commerce 463 packs
Distribution International only: including countries of : Abuja, Haiti, Indonesia, Natal, Nigeria, Senegal, South Africa, Uganda, and United Kingdom.
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 = GKZ and Original Applicant = POINTCARE TECHNOLOGIES INC.
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