Device recall
Z-0889-2013: Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x…
FDA device recall · Class II · Cellestis Inc
Key facts
| Recall number (Z-number) | Z-0889-2013 |
|---|---|
| Recall event | 64228 |
| Product | Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to… |
| Product code | NCD |
| Recalling firm | Cellestis Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2013 |
| PMA numbers | P010033 |
| FEI number | 3003964343 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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