VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c

FDA device recall Z-2073-2025 · posted 2025-07-02 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, Inc.

Reason for recall

Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.

Action taken

Quidel Ortho notified consignees on about 06/12/2025 via FedEx letter. Distributors were instructed to discontinue distribution and discard inventory of any affected lots, send the provided customer letter and Confirmation of Receipt to any affected customers, and complete and return their Confirmation of Receipt. Customers were instructed that if their laboratory is unable to generate QC results within acceptable range using lots from GEN 15 of VITROS OP Reagent, discontinue using, render unusable, and discard your inventory of VITROS OP Reagent, GEN 15. Additionally, there were requested to complete and return the Confirmation of Receipt, maintain the notification with all records, and provide the notification if affected units were further distributed.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DJG

Quantity affected

2,017 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal,

Date initiated

2025-06-12

Date posted

2025-07-02

Location

Rochester, NY

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