Recall Z-1269-2016 ยท OUG Medical Device Data System
Beckman Coulter Inc.
MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073 LabPro MBT Connect Systems v4
| Date | Feb 11, 2016 |
| Status | Terminated |
| Reason | Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status. |
| Root cause | Unknown/Undetermined by firm |
| Action | An Urgent Medical Device Recall Letter dated 2/11/2016 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.41. Beckman Coulter is expanding the recall that was initiated in July 2015 regarding FA-25776 for the MicroScan LabPro Information Manager System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Representative: http:www.beckmancou |
| Quantity | 2,702 units total (1,032 units in US) |
| Distribution | Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Po |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.