Drug recall
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
FDA recall event 76992 · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Event ID | 76992 |
|---|---|
| Recall numbers | Z-2085-2017, Z-2086-2017 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Product type | Devices |
| Products | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899, ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other… |
| Initiation date | Apr 5, 2017 |
| Report date | May 24, 2017 |
| Termination date | Apr 2, 2019 |
| 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: