The Recall Desk
ModerateFDA (Devices)·Z-0638-2016·Announced 2016-01-20

Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

Perkinelmer is recalling 188 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. The hazard involves potential erroneous results due to a labeling error, but no specific injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Perkinelmer is recalling 188 units of the WIZARD2 1-detector, 3-inch, 1000-sample gamma counter (Product Code: 2480-0010). 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 the United States and numerous international locations.

Consumers and healthcare facilities should contact Perkinelmer for instructions on how to correct the labeling error or replace the affected units. The recall number is Z-0638-2016.

The recalled product

Product
Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Manufacturer
Perkinelmer
Affected units
188

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 →