Drug recall
Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF…
FDA recall event 63167 · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Event ID | 63167 |
|---|---|
| Recall numbers | Z-0162-2013 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Product type | Devices |
| Products | Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges. |
| Initiation date | Sep 11, 2012 |
| Report date | Nov 7, 2012 |
| Termination date | Sep 1, 2016 |
| City | East Walpole |
| State | MA |
| Country | United States |
| FEI number | 1219913 |
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: