Device recall
Z-2170-2011: Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2170-2011 |
|---|---|
| Recall event | 58168 |
| Product | Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT)… |
| Product code | LCP |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2012 |
| 510(k) numbers | K031380 |
| FEI number | 2050012 |
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