Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error
Perkinelmer is recalling 54 WIZARD2 gamma counters worldwide due to a barcode label error that 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 is a potential for erroneous results without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Perkinelmer is recalling 54 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 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 such as Argentina, Australia, Brazil, Canada, China, France, Germany, India, Japan, and the UK. The recall covers 51 units of Model 2470-0100 and 3 units of Model 3470-0100.
Users should contact Perkinelmer for further instructions regarding the recall. The source text does not specify a specific action for consumers beyond the recall notice itself, nor does it report any illnesses or injuries associated with this defect.
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
- 54
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- SGWZ21130010
- SGWZ27140163
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.
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