FDA Device recall Z-0638-2016
Perkin Elmer WIZARD2 1-detector,3", 1000 samples
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of Perkin Elmer WIZARD2 1-detector,3", 1000 samples 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-0638-2016 |
| 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 1-detector,3", 1000 samples. Product Code: 2480-0010 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 | Serial Numbers: DG12107256 DG04106256 DG08118161 DG03117633 DG09118348 DG06117938 DG04106271 DG03117625 DG1111…Serial Numbers: DG12107256 DG04106256 DG08118161 DG03117633 DG09118348 DG06117938 DG04106271 DG03117625 DG11118603 DG03129003 DG11107087 DG09118269 DG09118346 DG09118323 DG09118410 DG10118462 DG12118695 DG03129030 DG05117802 DG04129089 DG11107086 DG03117631 DG10118453 DG01117421 DG04106256_REWORK DG06106456 DG03106146 DG11118564 DG03129000 DG02106095 DG08106711 DG02128912 DG10106940 DG07118046 DG07118051 DG03117635 DG09118273 DG05117890 DG12118657 DG09118349 DG03117557 DG10118483 DG10118478 DG11107160 DG04129156 DG02106081 DG09118167 DG02128958 DG03129032 DG03117634 DG11118575 DG08118256 DG05106334 DG10106910 DG10106950 DG03117630 DG05106409 DG07106656 DG12107176 DG05106333 DG05117810 DG10106978 DG03106122 DG12107186 DG08106662 DG05117817 DG05117874 DG02128962 DG11118610 DG03129033 DG03129034 DG12118735 DG11107053 DG09118307 DG07118070 DG09118306 DG08118170 DG02128953 DG02128936 DG03129053 DG08118162 DG11 |
|---|
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-0638-2016%22
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