The Recall Desk
ModerateFDA (Devices)·Z-0635-2016·Announced 2016-01-20

Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

Perkinelmer is recalling 47 WIZARD2 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, but the hazard is limited to erroneous measurement results due to a labeling error, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Perkinelmer is recalling 47 units of the WIZARD2 10-detector, 550 samples gamma counter (Product Codes 2470-0100 and 3470-0100). The recall is due to an error in the second #023 barcode ID label in the Barcode ID Label Binder. When scanned, this label incorrectly identifies as #024.

If measurement protocols have been programmed for both ID #023 and #024, the device will execute the protocol associated with barcode ID #024. If this error is undetected, the Gamma Counter may produce erroneous results. The affected units were distributed worldwide, including in the United States and numerous international locations.

Users should stop using the affected units and contact Perkinelmer for instructions on how to resolve the issue. The recall number is Z-0635-2016.

The recalled product

Product
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Manufacturer
Perkinelmer
Affected units
47

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 →