Drug recall
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of…
FDA recall event 37530 · Class III · Radiometer America Inc
Key facts
| Event ID | 37530 |
|---|---|
| Recall numbers | Z-0608-2013 |
| Recalling firm | Radiometer America Inc |
| Product type | Devices |
| Products | Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45. |
| Initiation date | Jun 6, 2006 |
| Report date | Jan 2, 2013 |
| Termination date | Feb 5, 2013 |
| City | Westlake |
| State | OH |
| Country | United States |
| FEI number | 1523456 |
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: