Z-1308-2023 Class II Ongoing
FDA device recall Z-1308-2023 was initiated by Quidel Corporation on February 1, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 771 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- February 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 771 units
Product Description
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 for Recall
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.
Distribution Pattern
not yet available
Code Information
UDI: 30014613335580; Lot Number: 213783