Recall Z-0850-06 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Kamiya Biomedical Company
K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap.
| Date | May 6, 2006 (initiated Apr 11, 2006) |
| Status | Terminated |
| Reason | Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent |
| Root cause | Other |
| Action | Customers were contacted via telephone on 4/11/06. Customers were asked to confirm the number of kits in their possession and then open the kits to verify which vials they received in their kits. If the kits contained both vials, then the customer was instructed to keep the kit. If the kits contained the wrong vials, then they were requested to return the kits. This was followed by a letter dated 4/17/06. The letter confirmed the telephone call and asked the customer to sign and return the letter to acknoweldge receipt of the letter. |
| Quantity | 185 kits |
| Distribution | Kits were distributed to laboratories nationwide. One foreign account in Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992312 | K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B Kamiya Biomedical Co., Sep 13, 1999 |