Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that ar

Hazard

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.

Details from the source

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. 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, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom. Quantity: 2,017 units Lot/code info: Model Number: 680 1997. UDI-DI: 10758750001835. Lot Numbers: 1527-15-2749 (exp. 17-Nov-2025), 1527-15-2771 (exp. 17-Dec-2025), 1527-15-2818 (exp. 11-Apr-2026), 1527-15-2871 (exp. 15-May-2026).

UPC codes

10758750001835

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.