Recall Z-1193-2012 ยท GKZ Counter, Differential Cell
Pointcare Technologies, Inc.
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
| Date | Mar 8, 2012 (initiated Nov 2, 2011) |
| Status | Terminated |
| Reason | Stability not assured at labeled temperature 2-42C |
| Root cause | 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 2-30C 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 supp |
| Quantity | 463 packs |
| Distribution | International only: including countries of : Abuja, Haiti, Indonesia, Natal, Nigeria, Senegal, South Africa, Uganda, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072869 | POINTCARE NOW SYSTEM Pointcare Technologies, Inc., Jan 14, 2008 |