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Phadia US Inc recalls EliA Sample Diluent, Article number, 83-1023-01
Recalled March 8, 2017 · FDA recall Z-1253-2017 · Phadia US
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. · FDA Class II
Units
5957
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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
Description
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.
Product
EliA Sample Diluent, Article number, 83-1023-01
Manufacturer(s)
Phadia US Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →