Recall Z-1049-2019 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
LW Scientific, Inc.
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
| Date | Feb 6, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 226 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.