Recall Z-1308-2023 ยท DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Quidel Corporation
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
| Date | Mar 30, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | An IMPORTANT: FIELD CORRECTIVE ACTION dated 1/27/23 was sent to customers. YOU NEED TO TAKE THE FOLLOWING ACTIONS: 1. Immediately quarantine any remaining inventory of MicroVue C1-Inhibitor, lot 213783. 2. Identify if these materials contain the affected Coated Strips, REF: 4634, with an ID number of 2200 or above. a. The ID number is printed on both the frame of the microtiter plate as well as on the external plate pouch label. 3. Affected Coated Strips will bear an ID number of 2200 or higher. For example, if the ID number found on the external plate pouch is 2350, then the plate is affecte |
| Quantity | 771 units |
| Distribution | not yet available |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY Cytotech, Inc., Jul 23, 1987 |