Class 2 Device Recall MicroVue C1Inhibitor Plus EIA

• Date Initiated by Firm: February 01, 2023
• Date Posted: March 30, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1308-2023
• Recall Event ID: 91772
• 510(K)Number: K872426
• Product Classification: Complement c1 inhibitor (inactivator), antigen, antiserum, control - Product Code DBA
• 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
• Code Information: UDI: 30014613335580; Lot Number: 213783
• FEI Number: 1000122536
• Recalling Firm/ Manufacturer: Quidel Corporation; 2005 E State St Ste 100; Athens OH 45701-2125
• For Additional Information Contact: 740-589-3300
• Manufacturer 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.
• FDA Determined 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 affected, and the entire kit contents should be permanently removed from inventory. 4. Report to Quidel the final count of kits removed from useable inventory using either the attached Confirmation of Action for End-Users (Attachment 1) or the Confirmation of Action for Distributors (Attachment 2) form. 5. Report to Quidel the number of used kits which produced failing results related to low OD values using the attached form. 6. Return the completed form to Quidel via fax at 740.592.9820 or email at customernotifications@quidel.com. 7. Upon completion and return of the Confirmation of Action form, Quidel will provide the requested replacement materials. Please feel free to contact Technical Support at technicalsupport@quidel.com or by calling 800.874.1517 (in the U.S.) or 858.552.1100 (outside the U.S) with any questions or concerns that you may have regarding this issue. End-User instructions: Please confirm that actions prescribed for the product shown below has been completed, sign and date below, then return completed form to Technical Support at: E-mail: customernotifications@quidel.com Fax: 740.592.9820 Distributor instructions: Please provide a copy of this communication to your affected customers and provide Quidel with their contact information in the space provided below. In addition, confirm that actions prescribed for the product shown below which remains in your possess
• Quantity in Commerce: 771 units
• Distribution: not yet available
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DBA