Perkinelmer: Medical Device Recall in 2013 - (Recall #: Z-0688-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 26, 2012

Date Posted: January 23, 2013

Recall Number: Z-0688-2013

Event ID: 63771

Reason for Recall:

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

Status: Terminated

Product Quantity: 3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)

Code Information:

Lot Numbers: 618201, 619200, 618263

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated