Drug recall
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product…
FDA recall event 85247 · Class II · Abbott Laboratories
Key facts
| Event ID | 85247 |
|---|---|
| Recall numbers | Z-1688-2020 |
| Recalling firm | Abbott Laboratories |
| Product type | Devices |
| Products | "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to… |
| Initiation date | May 22, 2019 |
| Report date | Apr 15, 2020 |
| Termination date | Jan 22, 2021 |
| City | Irving |
| State | TX |
| Country | United States |
| FEI number | 3016438761 |
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: