Drug recall
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South…
FDA recall event 66036 · Class II · Roche Molecular Systems, Inc.
Key facts
| Event ID | 66036 |
|---|---|
| Recall numbers | Z-2173-2013 |
| Recalling firm | Roche Molecular Systems, Inc. |
| Product type | Devices |
| Products | KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET… |
| Initiation date | Jul 25, 2013 |
| Report date | Sep 18, 2013 |
| Termination date | Aug 6, 2015 |
| City | Branchburg |
| State | NJ |
| Country | United States |
| FEI number | 2243471 |
At a glance
- 1–9 Products in this recall
- 10–99 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: