FDA Device recall Z-1357-2019
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when u…
- FDA Device
- Class III
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class III recall of ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when u… by Abbott Laboratories, citing devices were delivered without the required dry ice.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1357-2019 |
| 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 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 serum and plasma.
Reason
Devices were delivered without the required dry ice.
Identifiers
| code_info | LN 8K25-12; Lot 01018I000 |
|---|
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-1357-2019%22
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