The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1945-2020·Announced 2020-05-20

Beckman Coulter iQ200 Urine Analyzer Recalled for Electrical Short Risk

Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers due to a defect in the SATA power adapter cable that poses a risk of electrical short, charring, smoke, or flames.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire (flames and smoke) and electrical short, which constitutes a significant injury/property-damage risk under the rubric for Severe recalls.

Plain-English summary

Beckman Coulter Inc. is recalling 3,576 units of the iQ200 Series Urine Microscopy Analyzer, covering all part numbers. The recall affects units distributed nationwide in the United States and worldwide.

The recall is due to a defect in the SATA power adapter cable within the instrument's computer. This defect creates a potential risk for an electrical short. Such a short may lead to charring and/or melting of the cable within the computer's metal enclosure, smoke emanating from the PC6 component, flames contained within the PC6, or an inability to use the device's CD-ROM.

Affected units include catalog numbers 00-3322, 700-3325, 700-3326, 700-3345, 700-3347, 700-3370, 700-3375, 700-3300RFB, B48999, C10683, and C10684. Users should contact Beckman Coulter Inc. for instructions on how to address the defect.

The recalled product

Product
iQ200 Series Urine Microscopy Analyzer- All part numbers
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
3,576

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Catalog Numbers: 00-3322
  • 700-3325
  • 700-3326
  • 700-3345
  • 700-3347
  • 700-3370
  • 700-3375
  • 700-3300RFB
  • B48999
  • C10683
  • C10684.
  • All part numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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