Safety Alert for Commercial Name: CELLPACK D Technical Name: CAPS, DILUENTS AND OTHER SOLUTIONS FOR LABORATORY ANALYSIS ANVISA Registration Number: 80015490090 Hazard Class: I Model Affected: CELLPACK DCL Serial Numbers Affected: P5016 - SOLE LOT WITH THE ABOVE PROBLEM.

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

THE CUSTOMERS WHO PURCHASED THIS PRODUCT LOT WERE CONTACTED THROUGH E-MAIL AND POSSIBLE TELEPHONE CONNECTION, EXPLAINING THE INUTILIZATION OF THE LOTS ACQUIRED WITH THE ABOVE SUPRACITED PROBLEM, WHICH CONSISTS OF THE COMPLETE DISCARACTERIZATION OF THE HEALTH PRODUCT; BEYOND REFUND OF PRODUCTS. THE CUSTOMERS WERE INFORMED THAT THE USE OF THE PRODUCT DOES NOT INTERFERE IN THE QUALITY AND QUANTITY OF THE DIAGNOSTIC TESTS, AND THAT SUCH STATUS OF DISPOSAL OF PRODUCTS, APPLIES FOR PRIMAR FOR THE SAFETY AND TRACEABILITY OF THE BATCH IN QUESTION. LETTER OF COMMUNICATION WITH THE RECOMMENDATIONS TO THE CUSTOMER IN ANNEX.