MicroScan LabPro Information Manager System — Class II medical device recall Z-2809-2015
Terminated recall by Beckman Coulter Inc., reported 2015-09-30, distributed in MP, PR. The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually readin
| Recall number | Z-2809-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2015-07-17 |
| Classified | 2015-09-23 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2018-01-04 |
| Distributed | MP, PR |
| Countries outside the US | BE, BS, CA, CL, CN, CO, DE, ES, FR, GR, IL, IN, IT, JP, LT, MX, NL, PA, PL, PT, PY, RO, RU, SG, TR, UY, ZA |
| Reason classes | software |
| Model numbers | 10714149, 10714150 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2809-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.