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
FDA Recall Z-1193-2012 · Posted 2012-03-08
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Recalling FirmPointcare Technologies, Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2011-11-02
Date Terminated2012-04-26
Product Quantity463 packs
Reason for Recall
Stability not assured at labeled temperature 2-42C
Firm 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 2-30C as opposed to the previously claimed 2-42C. 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 2-30C 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 [email protected] or call our offices directly at 1-508-281-6925.
Root Cause
Storage
Distribution Pattern
International only: including countries of : Abuja, Haiti, Indonesia, Natal, Nigeria, Senegal, South Africa, Uganda, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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