Z-1308-2023Class II

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

Name: Z-1308-2023 MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or...
Creator: Quidel Corporation
Published: 2023-02-01
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-02-01 / Open, Classified / root cause: labeling and UDI

FDA source

Quidel Corporation began a recall of MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated... on 2023-02-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1308-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-30
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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
Product code: DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
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.
Root cause tag: labeling and UDI
FDA 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 [email protected]. 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 [email protected] 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: [email protected] 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
Product codes and lots: UDI: 30014613335580; Lot Number: 213783

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1308-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1308-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30

Product code DBA

K872426Class IICytotech C1-Inhibitor Enzyme ImmunoassayCytotech, Inc. / cleared 1987-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)