Recall Z-0686-2013— Perkinelmer

Name: FDA recall Z-0686-2013
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: K021541. Product: NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.. 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

K021541 — NEOGRAM PKU TANDEM MASS SPECTROMETRY KITPerkinelmer Life Sciences·cleared 2002-10-28

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

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.

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.