U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine - Product Code JNB
원인
Truncated v-bottomed microplate wells used in assays contain defective wells.
조치
Perkin Elmer initiated the recall on November 23, 2012. The Recall Letter will be delivered to the end customer by email facilitated through our PerkinElmer Technical Support group located in Akron Ohio.
Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions:
- Inspect the wells of row A and row H of the affected microplate lots for possible holes and cracks prior to use.
- If a hole or crack is visually detected in a well of the microplate, the well should not be used for testing.
- If a hole or crack is not visually detected in a well of the plate, it is required during use of the well, the volume of solution in the well should be visually confirmed to be consistent before and after incubation.
Please contact PerkinEimer Technical Support for further information (800) 321 -9632, select prompt 2.
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.