FDAJune 12, 2025device
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 are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
ortho clinical diagnosticsorthoortho clinical
UPCs
10758750001835
Recall history
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