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Terminated

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

FDA Recall Z-1050-2019 · Posted None

Recalling FirmLW Scientific, Inc.
Recall StatusTerminated
Product CodeJQC
Date Initiated2019-02-06
Date Terminated2021-05-07
Product Quantity16 units

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.

Firm Action

The recall was initiated by telephone on 02/06/2019. Initial requesting that the consignee immediately cease use of the product. Recall notices were disseminated by telephone and email requesting the return of the product beginning 02/13/2019. The recall is to the user level. The firm has posted a notice on their website stating there is a voluntary recall due to a safety issue and asking users to call if they have a unit purchased after 9/28/18.

Root Cause

Device Design

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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