Recall Z-0688-2013— Perkinelmer

Name: FDA recall Z-0688-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-26

Class II · Terminated

Class II FDA medical device recall by Perkinelmer, initiated 2012-11-26, terminated 2014-03-07. It names one FDA 510(k) clearance: K071649. Product: 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: Truncated V-Bottomed Microplate Wells used in assays contain defective wells..

Recalling firm: Perkinelmer
Classification: Class II
Status: Terminated
Initiated: 2012-11-26
Terminated: 2014-03-07
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BWallac OY·cleared 2008-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.