Class 2 Device Recall LW Scientific ZIP IQ Combo Centrifuge

• Date Initiated by Firm: February 06, 2019
• Create Date: March 23, 2019
• Recall Status: Terminated on May 07, 2021
• Recall Number: Z-1050-2019
• Recall Event ID: 82214
• Product Classification: Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
• 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
• Code Information: Serial Numbers: 6C1803035, 6C1803066, 6C1803121, 6C1803130, 6C1803132, 6C1803133, 6C1803139, 6C1803141, 6C1803142, 6C1803144, 6C1803145, 6C1805217, 6C1805242, 6C1805243, 6C1810375, 6C1810441
• Recalling Firm/ Manufacturer: LW Scientific, Inc.; 865 Marathon Pkwy; Lawrenceville GA 30046-2857
• For Additional Information Contact: Amanda Vander Iest; 770-270-1394 Ext. 43453
• Manufacturer 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.
• FDA Determined 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 in Commerce: 16 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.