Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling two WIZARD2 gamma counters 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of erroneous results in clinical testing, which fits the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Perkinelmer is recalling two units of the WIZARD2 5-detector, 1,000 samples gamma counter (Product Codes 2470-0150 and 3470-0150). The recall is due to an error in the WIZARD2 Barcode ID Label #023 content, which may produce erroneous results.
The affected units were distributed worldwide, including the United States and numerous international locations. The specific serial numbers for the recalled units are SGWZ36130042 (Model 2470-0150) and SGWZ19140141 (Model 3470-0150). The FDA has classified this recall as Class II.
Users should check their devices for these specific serial numbers and contact Perkinelmer for further instructions.
The recalled product
- Product
- Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
- Manufacturer
- Perkinelmer
- Affected units
- 2
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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