Drug recall
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of…
FDA recall event 82590 · Class III · Abbott Laboratories
Key facts
| Event ID | 82590 |
|---|---|
| Recall numbers | Z-1355-2019, Z-1356-2019, Z-1357-2019, Z-1358-2019, Z-1359-2019, Z-1360-2019, Z-1361-2019, Z-1362-2019, Z-1363-2019 |
| Recalling firm | Abbott Laboratories |
| Product type | Devices |
| Products | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of…, ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c…, ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in…, ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human…, ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human… and 4 more |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Devices were delivered without the required dry ice. |
| Initiation date | Apr 9, 2019 |
| Report date | May 22, 2019 |
| Termination date | Dec 20, 2019 |
| City | Abbott Park |
| State | IL |
| Country | United States |
| FEI number | 1415939 |
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: