FDA Device recall Z-2809-2015
MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150 by Beckman Coulter, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2809-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-17 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
Product
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).
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.
Identifiers
| code_info | Version 1.0 to Version 4.11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2809-2015%22
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