The Recall Desk
ModerateFDA (Devices)·Z-2124-2015·Announced 2015-07-29

Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

Perkinelmer is recalling 63 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error that may produce erroneous results without reported injuries or hospitalizations, fitting the Moderate criteria for minor labeling errors or low-risk issues.

Plain-English summary

Perkinelmer is recalling 63 units of the WIZARD2 1-detector, 550 samples gamma counter (Product Code: 2470-0010). The recall is due to an error in the WIZARD2 Barcode ID Label #023 content, which may produce erroneous results. The device is intended to detect and count gamma radiation emitted by clinical samples.

The affected units were distributed worldwide, including the United States and numerous international locations such as Argentina, Australia, Brazil, Canada, China, France, Germany, India, Japan, and the United Kingdom. Specific serial numbers for the 63 affected units are listed in the official recall documentation.

Healthcare facilities and users should stop using the affected WIZARD2 gamma counters and contact Perkinelmer for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Manufacturer
Perkinelmer
Affected units
63

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Perkinelmer 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 7 products in this recall →