FDA Device recall Z-1476-2024
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20 by Abbott Laboratories, citing the reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1476-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-21 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Reason
The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
Identifiers
| code_info | LN 2K43-25 - Lot number 50808UN23, exp. 11/30/2024, UDI (01)00380740003302 (17)241130(10)50808UN23; LN 2K43-20 - Lot n…LN 2K43-25 - Lot number 50808UN23, exp. 11/30/2024, UDI (01)00380740003302 (17)241130(10)50808UN23; LN 2K43-20 - Lot number 60104UN23, exp. 11/30/2024, UDI (01)00380740003296 (17)241130(10)60104UN23. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1476-2024%22
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