Safety Alert for Trade Name: CA SERIE 500/600 AUTOMATIC COAGULATION ANALYZER SYSMEX Technical Name: Apparatus For Determination of Coagulation Time ANVISA Registration Number: 10345161731 Hazard Class: I Model Affected: Sysmex CA-620; Sysmex CA-660 Affected serial numbers: 13659, 12180, 12183, 13072, 12556, 13658, 13891, 13126, 13384, 13656, 13836, 12769, 13129, 13230, 12182, 13988, 13989, 12188, 12189, 12187, 13073 , 12350, 13890, 12633, 12634, 13383, 13125, 12181, 12555, 13128, 13229, 12185, 12186, 13127, 12632, 12637, 12638, 12711, 12715, 12716, 12717, 12760, 12761, 13130, 12922, 13071 , 11753.

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.

1) If the "Barcoded Scanner Drive Error" message occurs during sample processing, or if the Bar Code Reader is blocked, and if the Bar Code Reader does not move to the # 1 to # 10 starting position . 2) Remove the lock or failure that may cause an error. 3) Before deleting the error, confirm in the display whether the equipment correctly assigned the number of samples. If any sample is erroneously identified, it should be deleted as described in the Operator's Manual in section "5.11 How to enter Sample No.". 4) Do not release the result and reanalyze the sample. Verify that all results in the sample rack correspond to the identified number. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.