Device recall
Z-0850-06: K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance…
FDA device recall · Class III · Kamiya Biomedical Company
Key facts
| Recall number (Z-number) | Z-0850-06 |
|---|---|
| Recall event | 35169 |
| Product | 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… |
| Product code | DCK |
| Recalling firm | Kamiya Biomedical Company |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 16, 2006 |
| 510(k) numbers | K992312 |
| FEI number | 2084025 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database