FDA recall Z-1050-2019

LW Scientific, Inc. · Class II · device

Product

LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips

Reason for recall

The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.

Distribution

Worldwide Distribution - US Nationwide and the countries of Philippines, Honduras, El Salvador, Australia, Guatemala, Canada, Singapore, Australia, Peru, Nicaragua, Trinidad and Tobago, and New Zealand

Key facts

Status
Terminated
Initiation date
2019-02-06
Report date
2019-04-03
Termination date
2021-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lawrenceville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2019