Drug recall
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the…
FDA recall event 83053 · Class III · Abbott Laboratories
Key facts
| Event ID | 83053 |
|---|---|
| Recall numbers | Z-2078-2019, Z-2079-2019 |
| Recalling firm | Abbott Laboratories |
| Product type | Devices |
| Products | ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide…, ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. |
| Initiation date | May 24, 2019 |
| Report date | Jul 31, 2019 |
| Termination date | Apr 1, 2021 |
| 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: