Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling 47 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 is classified as FDA Class II, but the hazard is limited to erroneous measurement results due to a labeling error, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Perkinelmer is recalling 47 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 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. If this error is undetected, the Gamma Counter may produce erroneous results. The affected units were distributed worldwide, including in the United States and numerous international locations.
Users should stop using the affected units and contact Perkinelmer for instructions on how to resolve the issue. The recall number is Z-0635-2016.
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
- 47
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
Same manufacturer · Perkinelmer
See all →- ModeratePerkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
FDA (Devices) · 2016-01-20
- ModeratePerkin Elmer ClWIZARD2 Gamma Counters Recalled for Barcode Label Error
FDA (Devices) · 2016-01-20
- ModeratePerkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error
FDA (Devices) · 2016-01-20
- ModeratePerkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error
FDA (Devices) · 2016-01-20
- ModeratePerkin Elmer WIZARD2 Gamma Counter Recalled for Incorrect Barcode Label
FDA (Devices) · 2016-01-20
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModeratePerkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error
FDA (Devices) · 2015-07-29
- HighPerkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
FDA (Devices) · 2015-07-29
- ModeratePerkinelmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
FDA (Devices) · 2015-07-29
- ModeratePerkinelmer Recalls WIZARD2 Gamma Counters Due to Barcode Label Error
FDA (Devices) · 2015-07-29
- LowPerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2020-06-10
- HighGEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk
FDA (Devices) · 2026-08-05