"K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by l
FDA device recall Z-0973-2010 · posted 2010-03-04 · Terminated
Recall details
- Recalling firm
- Kamiya Biomedical Company, LLC
- Reason for recall
- The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.
- Action taken
- 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 Company by calling 1- 206-575-8068.
- Root cause
- Other
- Status
- Terminated
- Product code
- DCK
- Quantity affected
- 3 kits each containing 5 x 2 ml vials
- Distribution
- United States (NY, NJ, and NC).
- Date initiated
- 2009-05-01
- Date posted
- 2010-03-04
- Date terminated
- 2011-01-21
- Location
- Tukwila, 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 C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR (K023828) | Kamiya Biomedical Co. | 2003-02-04 |