The Recall Desk
ModerateFDA (Devices)·Z-0634-2016·Announced 2016-01-20

Perkin Elmer ClWIZARD2 Gamma Counters Recalled for Barcode Label Error

Perkinelmer is recalling 62 ClWIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing 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 a labeling error that may lead to erroneous results, which aligns with the criteria for moderate severity involving minor labeling errors or low-risk issues without reported harm.

Plain-English summary

Perkinelmer is recalling 62 units of the ClWIZARD2 5-detector, 550 samples gamma counter (Product Codes 2470-0050 and 3470-0050). The recall is due to an error in the second #023 barcode ID label in the Barcode ID Label Binder. When scanned, the symbol incorrectly identifies as #024. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed instead of the intended one.

The affected units were distributed worldwide, including the United States and numerous international locations such as Argentina, Australia, Canada, China, and the United Kingdom. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Consumers and healthcare facilities should contact Perkinelmer for instructions on how to correct the barcode label error to ensure accurate measurement protocols are executed.

The recalled product

Product
Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Manufacturer
Perkinelmer
Affected units
62

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 →