Recall Z-1308-2023— Quidel Corporation

Name: FDA recall Z-1308-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-01

Class II · Ongoing

Class II FDA medical device recall by Quidel Corporation, initiated 2023-02-01. It names one FDA 510(k) clearance: K872426. 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. 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..

Recalling firm: Quidel Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-02-01
Firm location: Athens, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K872426 — CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAYCytotech, Inc.·cleared 1987-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.