Z-1253-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2017
- Initiation Date
- January 30, 2017
- Termination Date
- August 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5957
Product Description
EliA Sample Diluent, Article number, 83-1023-01
Reason for Recall
Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
Distribution Pattern
Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None
Code Information
EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C