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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
데이터 추가 비고
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.
Microplate, truncated V-bottomed lots included in the || above listed products || Product Number: 1380 5465. || DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.