FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1308-2023
- Recalling firm
- Quidel Corporation
- 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
- Status
- Open, Classified
- Initiated
- 2023-02-01
- Posted
- 2023-03-30
- Terminated
- not on file
- 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 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
- 771 units
- Distribution
- not yet available
- Lot, serial or model codes
- UDI: 30014613335580; Lot Number: 213783
- 510(k) numbers
- ["K872426"]
- PMA numbers
- not on file
- Product code
- DBA
- Firm FEI
- 1000122536
- Firm city
- Athens
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28