Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error
Perkinelmer is recalling 60 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, leading to 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 a labeling error that may lead to erroneous measurement results, but no injuries or illnesses are reported in the source text.
Plain-English summary
Perkinelmer is recalling 60 units of the WIZARD2 2-detector, 550 samples gamma counter (Product Code: 2470-0020). 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 US and numerous international locations.
Users of these devices should check their serial numbers against the list provided by the FDA and contact Perkinelmer for instructions on how to correct the labeling issue.
The recalled product
- Product
- Perkin Elmer 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
- 60
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 →Related recalls
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