Device recall
Z-2066-2015: G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated…
FDA device recall · Class III · Tosoh Bioscience, Inc.
Key facts
| Recall number (Z-number) | Z-2066-2015 |
|---|---|
| Recall event | 71493 |
| Product | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. |
| Product code | LCP |
| Recalling firm | Tosoh Bioscience, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 1, 2015 |
| 510(k) numbers | K011434 |
| FEI number | 1000123732 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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