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Recall Observatory FDA recall evidence

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

Z-1050-2019

February 06, 2019

Class II

Product summary

Firm
LW Scientific, Inc.
Event
Event 82214
Status
Terminated
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-1050-2019

Official wording

Reason: 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.

Code information: Serial Numbers: 6C1803035, 6C1803066, 6C1803121, 6C1803130, 6C1803132, 6C1803133, 6C1803139, 6C1803141, 6C1803142, 6C1803144, 6C1803145, 6C1805217, 6C1805242, 6C1805243, 6C1810375, 6C1810441

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.