Drug recall
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and…
FDA recall event 70918 · Class II · Ortho-Clinical Diagnostics
Key facts
| Event ID | 70918 |
|---|---|
| Recall numbers | Z-1728-2015, Z-1729-2015 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Product type | Devices |
| Products | Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine…, VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample… |
| Initiation date | Apr 6, 2015 |
| Report date | Jun 17, 2015 |
| Termination date | May 25, 2018 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000136573 |
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: