VITROS Chemistry Products URIC Slides recall
VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY…
Why was VITROS Chemistry Products URIC Slides recalled?
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.
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?
Current/In-date GENs 26, 27, 28, 29, 31
- Product
- VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- US: 18,749 sales units; Foreign: 94,928 sales units
- Distribution
- Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)