Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling 22 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a labeling error that may lead to erroneous results, but no injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Perkinelmer is recalling 22 units of the WIZARD2 10-detector, 1000 samples gamma counter (Product Codes: 2470-0200, 3470-0200). 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 instead of #023. If this error is undetected, the gamma counter may produce erroneous results for clinical samples.
The affected units were distributed worldwide, including the United States and numerous international locations. Users should stop using the affected units and contact Perkinelmer for further instructions.
The recalled product
- Product
- Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
- Manufacturer
- Perkinelmer
- Affected units
- 22
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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