Agency classClass IIOur severity:High FDA (Devices)·Z-0082-2015·Announced 2014-10-22

Siemens Clinitek Status Power Supply Adaptors Recalled for Shock Risk

Siemens Healthcare Diagnostics is recalling external power supply adaptors 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 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 electric shock, which is a risk-of-harm product hazard. No specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling approximately 4,200 external power supply adaptors that accompany the Clinitek Status Connect System. The Clinitek Status system is a urine analyzer. The recall covers specific product codes and date codes embossed on the adaptors.

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

Users of the Clinitek Status system should check their power supply adaptors against the specific product and date codes listed in the official recall notice. If the adaptors match the recalled items, users should stop using them and contact Siemens Healthcare Diagnostics for instructions on replacement or repair.

The recalled product

Product: External power supply adaptors that accompany Clinitek Status Connect System 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)

10703923
10704041
10376322
10376323
10470849
(Legacy P/N: 1797
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