Recall Z-0687-2013— Perkinelmer
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: K083130. Product: NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.. 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 recordK-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
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
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.