VITROS Chemistry OP Reagent Generation 15 Quality Control Failure
VITROS Chemistry OP Reagent Gen 15 may generate lower-than-expected quality control results, preventing use of the OP-LO protocol and potentially delaying patient test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is FDA Class II with no reported illnesses, injuries, or hospitalizations. The recall addresses a quality control defect affecting product performance rather than direct patient harm.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling Generation 15 of VITROS Chemistry OP Reagent (Model 680 1997), a medical device used to detect opiates in urine. The product is a dual-chambered package containing ready-to-use liquid reagents; each sales unit contains 6 Microtip packs with 50 tests per pack.
These lots may generate lower-than-expected quality control results. Customers unable to obtain passing quality control results cannot run the OP-LO protocol, potentially delaying patient test results.
Approximately 2,017 units have been distributed to the United States and internationally to 21 countries including Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom. The recalled lot numbers are 1527-15-2749, 1527-15-2771, 1527-15-2818, and 1527-15-2871, with expiration dates ranging from November 2025 to May 2026.
The recalled product
- 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 reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- qc-failure
- performance-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 1527-15-2771 (exp. 17-Dec-2025)
- 1527-15-2818 (exp. 11-Apr-2026)
- 1527-15-2871 (exp. 15-May-2026).
Distribution
Distributed nationwide across the United States.
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