Recall Z-0973-2010 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Kamiya Biomedical Company, LLC
"K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.
| Date | Mar 4, 2010 (initiated May 1, 2009) |
| Status | Terminated |
| Reason | The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration. |
| Root cause | Other |
| Action | On May 1, 2009 the recalling firm, Kamiya Biomedical Company contacted the 3 consignees by telephone and notified them of the issue. A follow-up e-mail notification on May 4, 2009 was sent to consignees requesting to return the affected product to Kamiya Biomedical Company for a free replacement kit. After the e-mail notifications, an Urgent Medical Device Recall Notice dated May 13, 2009 was also sent to consignees describing the issue and actions to take for returning opened and unopened affected product to the recalling firm for replacement. Direct questions to the Kamiya Biomedical Comp |
| Quantity | 3 kits each containing 5 x 2 ml vials |
| Distribution | United States (NY, NJ, and NC). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR Kamiya Biomedical Co., Feb 4, 2003 |