Drug recall
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome…
FDA recall event 65084 · Class II · Wako Life Sciences, Inc.
Key facts
| Event ID | 65084 |
|---|---|
| Recall numbers | Z-1831-2013 |
| Recalling firm | Wako Life Sciences, Inc. |
| Product type | Devices |
| Products | uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product fails to meet the accuracy at the low end of the measuring range. |
| Initiation date | Apr 30, 2013 |
| Report date | Aug 7, 2013 |
| Termination date | Aug 19, 2013 |
| City | Mountain View |
| State | CA |
| Country | United States |
| FEI number | 3009907123 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: