FDA Device recall Z-1355-2019
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when…
- FDA Device
- Class III
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class III recall of ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when… by Abbott Laboratories, citing devices were delivered without the required dry ice.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1355-2019 |
| 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 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 whole blood.
Reason
Devices were delivered without the required dry ice.
Identifiers
| code_info | LN 1L76-01; Lot 46K15718 |
|---|
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-1355-2019%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.