Recall Z-0637-2016— Perkinelmer
Class II · Terminated
Class II FDA medical device recall by Perkinelmer, initiated 2015-12-08, terminated 2017-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. 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..
- Recalling firm
- Perkinelmer
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-08
- Terminated
- 2017-08-04
- Firm location
- Waltham, MA, United States
Product description
Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.