FDA Device recall Z-1308-2023
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, C…
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, C… by Quidel, citing kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1308-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-01 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Quidel |
| Distribution | n/a |
Product
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Reason
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Identifiers
| code_info | UDI: 30014613335580; Lot Number: 213783 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1308-2023%22
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