FDA Device recall Z-0634-2016
Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 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-0634-2016 |
| 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 ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 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: 2470-0050 Serial Numbers: DG05106329 DG02117493 DG11107166 DG09106782 DG07118133 DG07118141 DG09106791…Model: 2470-0050 Serial Numbers: DG05106329 DG02117493 DG11107166 DG09106782 DG07118133 DG07118141 DG09106791 DG04117727 DG06118036 DG12107192 DG02106101 DG04106223 DG01128843 DG12107272 DG07118124 DG09106892 DG12118684 DG12118673 DG11107126 DG04117704 DG04117763 DG01117363 DG06106484 DG12107240 DG01128871 DG05117880 DG12118685 DG09118357 DG03106204 DG05106386 DG11107137 DG03106172 DG03106206 DG02106113 DG09106818 DG02106065 DG04106309 DG09106882 DG11118590 DG06106483 DG01117316 DG08118221 DG06117898 DG12107263 DG08118250 DG12118711 DG04117710 DG06106448 DG06106453 DG06106463 DG06117912 DG03106135 DG01117373 DG05117837 DG06106517 DG01128805 DG06117970 DG04106310 DG02117521 DG06106538 Model: 3470-0050 (2 units) Serial Numbers: DG12118660 DG10118464 |
|---|
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-0634-2016%22
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