Drug recall
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG)…
FDA recall event 71006 · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Event ID | 71006 |
|---|---|
| Recall numbers | Z-1629-2015 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Product type | Devices |
| Products | IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed… |
| Initiation date | Apr 9, 2015 |
| Report date | May 27, 2015 |
| Termination date | Mar 22, 2017 |
| City | Tarrytown |
| State | NY |
| Country | United States |
| FEI number | 2432235 |
At a glance
- 1–9 Products in this recall
- None 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: