FDA Device recall Z-0891-2022
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem…
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem… by Abbott Laboratories, citing this calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0891-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-08 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
Reason
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
Identifiers
| code_info | UDI: (01)00380740003272(17)220531(10)166000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0891-2022%22
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