Home / Recalls / Perkinelmer / Z-0688-2013

Z-0688-2013 Class II Terminated

Recalled by Perkinelmer — Waltham, MA

Recall Details

Product Type
Devices
Report Date
January 23, 2013
Initiation Date
November 26, 2012
Termination Date
March 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)

Product Description

NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.

Reason for Recall

Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

Distribution Pattern

Nationwide Distribution.

Code Information

Lot Numbers: 618201, 619200, 618263

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