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MicroVue C1-Inhibitor Plus EIA for measuring the amount of… recallZ-1308-2023 · Quidel Corporation · initiated Feb 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Quidel Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Release of Material/Component prior to receiving test results

What the company is doing

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

Recall details

Recall number
Z-1308-2023
Status
Open, Classified
Initiated by the company
Feb 1, 2023
Posted by the FDA
Mar 30, 2023
Recalling firm
Quidel Corporation
Quantity
771 units
Product code
DBA
FDA submissions
K872426
Distribution
not yet available

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

Code information (models, lots, serial numbers)

UDI: 30014613335580; Lot Number: 213783

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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