Perkinelmer Recalls WIZARD2 Gamma Counters Due to Barcode Label Error
Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce 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 is classified as FDA Class II, and the hazard involves potential erroneous results rather than direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Perkinelmer is recalling 53 units of the WIZARD2 5-detector, 550 samples gamma counter (Product Codes 2470-0050, 3470-0050). The recall is due to an error in the WIZARD2 Barcode ID Label #023 content, which may produce erroneous results.
The affected devices were distributed worldwide, including the United States and numerous international locations. The recall covers specific serial numbers listed in the agency's official record.
Consumers and healthcare facilities should contact Perkinelmer for instructions on how to address the label error and ensure accurate sample counting.
The recalled product
- Product
- WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
- Manufacturer
- Perkinelmer
- Affected units
- 53
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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