CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report
ZIP IQ Combo Centrifuge, Zic-cmbo-4RT3 Rev B recalled by LW Scientific
LW Scientific is recalling ZIP IQ Combo Centrifuge, Zic-cmbo-4RT3, distributed nationwide in the US. The recall was initiated on 6 Feb 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1050-2019
- FDA event ID
- 82214
- Recalling firm
- LW Scientific, Lawrenceville, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2019
- FDA classified
- 22 Mar 2019
- Reported
- 3 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Feb 2019 | Recall initiated by company | |
| 22 Mar 2019 | Classified by FDA | +44 days |
| 3 Apr 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
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
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 6C1803035, 6C1803066, 6C1803121, 6C1803130, 6C1803132, 6C1803133, 6C1803139, 6C1803141, 6C1803142, 6C1803144, 6C1803145, 6C1805217, 6C1805242, 6C1805243, 6C1810375, 6C1810441
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 82214This product is part of a recall event; the main page for the event is ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C recalled by LW Scientific.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C recalled by LW Scientific | LW Scientific | Foreign Material | Nationwide | |
| CLASS II | ZIP IQ Combo Centrifuge, Zic-cmbo-2RT3 Rev B recalled by LW Scientific | LW Scientific | Foreign Material | Nationwide |
More recalls from LW Scientific
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ZIP IQ Combo Centrifuge, Zic-cmbo-2RT3 Rev B recalled by LW Scientific | LW Scientific | Foreign Material | Nationwide |
| Device | CLASS II | ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C recalled by LW Scientific | LW Scientific | Foreign Material | Nationwide |
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