FDADecember 8, 2015device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

perkinelmer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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