K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labele
FDA device recall Z-0850-06 · posted 2006-05-06 · Terminated
Recall details
- Recalling firm
- Kamiya Biomedical Company
- Reason for recall
- Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DCK
- Quantity affected
- 185 kits
- Distribution
- Kits were distributed to laboratories nationwide. One foreign account in Singapore.
- Date initiated
- 2006-04-11
- Date posted
- 2006-05-06
- Date terminated
- 2006-05-16
- Location
- Seattle, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B (K992312) | Kamiya Biomedical Co. | 1999-09-13 |