FDA Device recall Z-1356-2019
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used fo…
- FDA Device
- Class III
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class III recall of ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used fo… by Abbott Laboratories, citing devices were delivered without the required dry ice.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1356-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-09 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | n/a |
Product
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 (HbA1c) in human whole blood.
Reason
Devices were delivered without the required dry ice.
Identifiers
| code_info | LN 4P72-01; Lot 902920500 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1356-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.