Phadia US Inc recalls EliA Sample Diluent, Article number, 83-1023-01

Recall date

January 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1253-2017

FDA classification

Class II

Brand / firm

Phadia US Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EliA Sample Diluent, Article number, 83-1023-01