FDA-Device2017-03-08Class II
EliA Sample Diluent, Article number, 83-1023-01
Phadia US Inc
Hazard
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.
Sold states
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
Affected count
5957
Manufactured in
4169 Commercial Ave, N/A, Portage, MI, United States
Products
EliA Sample Diluent, Article number, 83-1023-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1253-2017Don't want to check this manually?
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