MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Cat

FDA device recall Z-1308-2023 · posted 2023-03-30 · Open, Classified

Recall details

Recalling firm

Quidel Corporation

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.

Action taken

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

Root cause

Release of Material/Component prior to receiving test results

Status

Open, Classified

Product code

DBA

Quantity affected

771 units

Distribution

not yet available

Date initiated

2023-02-01

Date posted

2023-03-30

Location

Athens, OH

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