Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0636-2016·Announced 2016-01-20

Perkin Elmer WIZARD2 Gamma Counter Recalled for Incorrect Barcode Label

Perkinelmer is recalling four WIZARD2 gamma counters because a barcode label misidentifies sample ID #023 as #024, which may cause the device to execute the wrong measurement protocol and 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 due to a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Perkinelmer is recalling four units of the WIZARD2 5-detector, 1000 samples gamma counter (Product Codes 2470-0150 and 3470-0150). The recall is due to an error in the Barcode ID Label Binder where the second barcode ID label #023 incorrectly identifies as #024 when scanned.

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 are identified by the following serial numbers: DG04129084, DG12118776, DG04117773, and DG05106408. These units were distributed worldwide, including the United States and numerous international locations. Users should contact Perkinelmer for instructions on how to resolve the labeling issue.

The recalled product

Product: Perkin Elmer WIZARD2 5-detector, 1000 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
Category: Medical Device — Laboratory Equipment
Hazard: mis-labeling
erroneous-results
Affected units: 4

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 (1)

Serial Numbers: DG04129084 DG12118776 DG04117773 DG05106408

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 →

Same manufacturer · Perkinelmer

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Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
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Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error
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Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error
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Same hazard · mis labeling