Device recall
Z-1671-2014: ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1671-2014 |
|---|---|
| Recall event | 67527 |
| Product | ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin… |
| Product code | JIT |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2015 |
| 510(k) numbers | K063232 |
| FEI number | 1415939 |
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