Horiba Instruments Inc recalls Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers…

Recall date

February 19, 2016

Source

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

Recall number

Z-1554-2016

FDA classification

Class II

Brand / firm

Horiba Instruments Inc

Sold / distributed

USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.

Why it was recalled

Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.

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

What was recalled

Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.