VITROS Chemistry Products OP Reagent Gen 15 recall
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…
Why was VITROS Chemistry Products OP Reagent Gen 15 recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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).
- Product
- 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…
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 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, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Recall date
- July 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)