The Recall Desk
ModerateFDA (Devices)·Z-2125-2015·Announced 2015-07-29

Perkinelmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error 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 involves potential erroneous results without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Perkinelmer is recalling 53 units of the WIZARD2 2-detector, 550 samples gamma counter (Product Code: 2470-0020). The recall is due to an error in the WIZARD2 Barcode ID Label #023 content, which may produce erroneous results.

The affected devices are intended to detect and count gamma radiation emitted by clinical samples. The recall covers units distributed worldwide, including the United States and numerous international locations.

Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice. If a device is affected, users should contact Perkinelmer for instructions on how to proceed.

The recalled product

Product
WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Manufacturer
Perkinelmer
Affected units
53

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 →