Recall Z-2809-2015 ยท OUG Medical Device Data System
Beckman Coulter Inc.
MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
| Date | Sep 23, 2015 (initiated Jul 17, 2015) |
| Status | Terminated |
| Reason | 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 7/17/2015 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11. 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. 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 wi |
| Quantity | 2,456 units total (1,034 units total) |
| Distribution | Worldwide distribution: United States (including Puerto Rico), Bahamas, Belgium, Canada, Chile, China, Colombia, France, French Guiana, Germany, Greece, Guadeloupe, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Romania, Russia, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.