FDA Device recall Z-0635-2016
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 by Perkinelmer, citing the content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0635-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-08 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer |
| Distribution | US |
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
Reason
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Identifiers
| code_info | Model Number: 2470-0100 Serial Numbers: DG06106436 DG08118240 DG02106050 DG06106502 DG11118609 DG01128795 DG021…Model Number: 2470-0100 Serial Numbers: DG06106436 DG08118240 DG02106050 DG06106502 DG11118609 DG01128795 DG02117461 DG12118702 DG09106861 DG05117833 DG05117834 DG10107006 DG06106452 DG09118367 DG03106154 DG04129081 DG06106559 DG06117903 DG07106599 DG09106774 DG05106387 DG06106524 DG10106949 DG09118284 DG05117787 DG04117755 DG09106770 DG03106196 DG04129159 DG08118192 DG06106469 DG08118189 DG04129075 DG12107252 DG12118677 DG06117923 DG08106741 DG03106186 DG12118759 DG01117444 DG02106112 DG12107236 DG11107031 DG12107249 DG11118612 DG05117781 Model: 3470-0100 (1 unit) Serial Number: DG02128911 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0635-2016%22
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