The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1944-2020·Announced 2020-05-20

Beckman Coulter iChem VELOCITY Urine Chemistry System Recalled for Fire Risk

Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Systems due to a defect in the SATA power adapter cable that poses a risk of electrical short, 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 1,557 units of the iChem VELOCITY Urine Chemistry System. The recall involves catalog numbers #700-7176-001 and #700-7177-001, covering all part numbers. The affected units were 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 or melting of the cable within the metal enclosure, smoke emanating from the PC6 component, flames contained within the PC6, or an inability to use the device's CD-ROM.

Users of the iChem VELOCITY Urine Chemistry System should stop using the device and contact Beckman Coulter Inc. for instructions on how to proceed with the recall.

The recalled product

Product
iChem¿VELOCITY Urine Chemistry System-
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
1,557

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 (2)

  • Catalog #700-7176-001 and #700-7177-001
  • 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 →

Related recalls

Same manufacturer · Beckman Coulter Inc.

See all →

Same hazard · fire

See all →

Similar recalls