Perkinelmer: Medical Device Recall in 2013 - (Recall #: Z-0686-2013)

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:

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.

Product Classification:

Class II

Date Initiated: November 26, 2012

Date Posted: January 23, 2013

Recall Number: Z-0686-2013

Event ID: 63771

Reason for Recall:

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

Status: Terminated

Product Quantity: 180 kits (20 plates/kit)

Code Information:

Lot Numbers: 617341, 619236

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated