Oartrac Plus Clinical Detector Unit recall
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer…
Why was Oartrac Plus Clinical Detector Unit recalled?
May result in readings outside of the expected accuracy range.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot Numbers: 025-001-055-A-003, 025-001-055-A-005, 025-001-055-A-007, 025-001-055-A-008 UDI: 00851546007196
- Product
- OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer…
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
- Recall date
- December 25, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)