PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro Diagnostic : Assay reagent intended fo
FDA device recall Z-1193-2012 · posted 2012-03-08 · Terminated
Recall details
- Recalling firm
- Pointcare Technologies, Inc.
- Reason for recall
- Stability not assured at labeled temperature 2-42C
- Action taken
- 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 customersupport@pointcare.net or call our offices directly at 1-508-281-6925.
- Root cause
- Storage
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 463 packs
- Distribution
- International only: including countries of : Abuja, Haiti, Indonesia, Natal, Nigeria, Senegal, South Africa, Uganda, and United Kingdom.
- Date initiated
- 2011-11-02
- Date posted
- 2012-03-08
- Date terminated
- 2012-04-26
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POINTCARE NOW SYSTEM (K072869) | Pointcare Technologies, Inc. | 2008-01-14 |