Perkin Elmer WIZARD2 1-detector — Class II medical device recall Z-0638-2016
Terminated recall by Perkinelmer, reported 2016-01-20, distributed nationwide. The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcod
| Recall number | Z-0638-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perkinelmer, Waltham, MA, United States |
| Recall initiated | 2015-12-08 |
| Classified | 2016-01-12 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2017-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, BR, CA, CH, CN, DE, DK, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, KW, NL, NO, NZ, PL, PT, SA, SE, SG, SK, TH, TW, ZA |
| Quantity | 188 units |
| Reason classes | labeling |
| Serial numbers | DG01105987, DG01106026, DG01117421, DG01128794, DG01128802, DG01128809, DG01128829, DG01128838, DG01128850, DG01128854, DG01128856, DG01128861, DG02106081, DG02106083, DG02106095, DG02117463, DG02117474, DG02117542, DG02128879, DG02128895, DG02128898, DG02128912, DG02128918, DG02128927, DG02128933 and 161 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0638-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.