LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B
LW Scientific, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1050-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- LW Scientific, Inc.
- 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
- Product code
- JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- 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.
- Root cause tag
- design
- FDA 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 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
- Product codes and lots
- Serial Numbers: 6C1803035, 6C1803066, 6C1803121, 6C1803130, 6C1803132, 6C1803133, 6C1803139, 6C1803141, 6C1803142, 6C1803144, 6C1803145, 6C1805217, 6C1805242, 6C1805243, 6C1810375, 6C1810441
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1048-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1049-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1050-2019 | Class II | Terminated | Voluntary: Firm initiated |
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