1) Vitros 5 recall
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For…
Why was 1) Vitros 5 recalled?
There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
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?
Serial numbers: 1) J34000240, J34000714, J34001562 and J34002163 through J34002245, 2) 34000193, 34000420, 34000478, 34000495, 34000497, 34000529, 34000596, 34000799, 34000805, 34000947, 34001243, 34001422, 34001504, 34001569, 34001589, 34001610, 34001633
- Product
- 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- Total 101 units (84 units for # 6801375- 26 units domestic & 58 units foreign) and (17 units for # 6801890-15 units domestic, 2 units foreign)
- Distribution
- Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain
- Recall date
- July 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)