Agency classClass IIOur severity:High FDA (Devices)·Z-0083-2015·Announced 2014-10-22

Siemens Clinitek Status Power Supply Adaptors Recalled for Electric Shock Risk

Siemens Healthcare Diagnostics is recalling external power supply adaptors for the Clinitek Status urine analyzer because they are damaged and 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electric shock) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling approximately 4,200 external power supply adaptors that accompany the Clinitek Status Power Supply Adaptor. The Clinitek Status system is a urine analyzer. The affected units are identified by specific part numbers and date codes embossed on the adaptors.

The recall is being issued because the external power supply is damaged, which can result in an electric shock to the user. The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous international locations.

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

The recalled product

Product: External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
Manufacturer: Siemens Healthcare Diagnostics, Inc
Category: Medical Device — Power Supply
Hazard: electric-shock
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)

10378632
10378633
10378634
10309177
10309178
10324040
51130
52130
01140
02140
03140
04140
05140
06140
07140
08140
09140
10140
11140
12140

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 →

Same manufacturer · Siemens Healthcare Diagnostics, Inc

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Same hazard · electric shock