Device recall
Z-0653-03: Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing…
FDA device recall · Class II · Simmler Inc
Key facts
| Recall number (Z-number) | Z-0653-03 |
|---|---|
| Recall event | 25233 |
| Product | Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution (80% Reagent Alcohol), 3 x 120ml Fetal Cell Citrate Buffer Solution (Citrate Buffer, 0.081M), and 3 x 120ml Fetal Cell Stain (Erythrosin-B, Fast Green). The responsible firm on the label is Simmler, Inc., St… |
| Recalling firm | Simmler Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2004 |
| FEI number | 1950226 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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