CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
iQ200 Series Urine Microscopy Analyzer- All part numbers recalled
Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzer- All part numbers, distributed nationwide in the US. The recall was initiated on 30 Mar 2020 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-1945-2020
- FDA event ID
- 85423
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2020
- FDA classified
- 8 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Mar 2020 | Recall initiated by company | |
| 8 May 2020 | Classified by FDA | +39 days |
| 20 May 2020 | 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
A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.
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
iQ200 Series Urine Microscopy Analyzer- All part numbers
Where it was distributed
US Distribution: Nationwide Foreign Distribution: Worldwide
Questions about this recall
Is iQ200 Series Urine Microscopy Analyzer- All part numbers recalled?
Yes. Beckman Coulter recalled iQ200 Series Urine Microscopy Analyzer- All part numbers on 30 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-1945-2020.
Why was it recalled?
A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.
Which lots are affected?
Catalog Numbers: 00-3322, 700-3325, 700-3326, 700-3345, 700-3347, 700-3370, 700-3375, 700-3300RFB, B48999, C10683, C10684., All part numbers
Where was it sold?
US Distribution: Nationwide Foreign Distribution: Worldwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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