Drug recall
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No…
FDA recall event 74355 · Class II · Ortho-Clinical Diagnostics
Key facts
| Event ID | 74355 |
|---|---|
| Recall numbers | Z-2273-2016 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Product type | Devices |
| Products | VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or… |
| Initiation date | May 18, 2016 |
| Report date | Aug 3, 2016 |
| Termination date | Jun 8, 2018 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000305840 |
At a glance
- 1–9 Products in this recall
- 1–9 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: