Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
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, based on matches of recall data from the U.S. and Canada.
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원인
Beckman coulter has confirmed the presence of deformed well terraces in the pk microplate wells may cause fold over or slip down of positive reaction patterns in the pk7200 and pk7300 automated microplate system.
Model Catalog: PK7200 (Lot serial: P4-93B94B99C); Model Catalog: PK7200 (Lot serial: FOR MICROPLATES:); Model Catalog: PK7200 (Lot serial: P3-91A92A93A95D96D); Model Catalog: PK7300 (Lot serial: FOR MICROPLATES:); Model Catalog: PK7300 (Lot serial: P4-93B94B99C); Model Catalog: PK7300 (Lot serial: P3-91A92A93A95D96D)
제품 설명
P3 P4 PLATES FOR THE PK7200 AUTOMATED MICROPLATE SYSTEM-ANALYZER CLASS 3