The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0081-2015·Announced 2014-10-22

Siemens Clinitek Status+ Power Supply Adapters Recalled for Electric Shock Risk

Siemens Healthcare Diagnostics is recalling approximately 4,200 external power supply adapters for the Clinitek Status+ urine analyzer due to damage that can cause electric shock.

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 electric shock, which is a significant injury hazard. Per the rubric, risk-of-harm products where injury has not yet been reported but the hazard is significant (electric shock) aligns with a Severe classification, particularly given the potential for serious injury from electrical faults.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling approximately 4,200 external power supply adapters that accompany the Clinitek Status+ urine analyzer. The recall is being conducted because the external power supply is damaged, which can result in an electric shock to the user.

The affected products are identified by part numbers 10379675 through 10379681 and 10376324 (Legacy P/N: 1780). These adapters are embossed with specific numerical date codes ranging from 50130 to 23140. The products were distributed worldwide, including the United States (nationwide and Puerto Rico), Canada, Mexico, and numerous international locations.

Users should stop using the affected power supply adapters immediately to avoid the risk of electric shock. Siemens Healthcare Diagnostics is the recalling firm responsible for this action.

The recalled product

Product
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Manufacturer
Siemens Healthcare Diagnostics, Inc
Category
Medical Device — Power Supply
Hazard
Affected units
4,200

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 (20)

  • 10379675
  • 10379676
  • 10379677
  • 10379678
  • 10379679
  • 10379680
  • 10379681
  • 10376324
  • 51130
  • 52130
  • 01140
  • 02140
  • 03140
  • 04140
  • 05140
  • 06140
  • 07140
  • 08140
  • 09140
  • 10140

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Siemens Healthcare Diagnostics, 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 3 products in this recall →

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