MicroScan Pos MIC Panel Type 34 — Class II medical device recall Z-0720-2021
Terminated recall by Beckman Coulter Inc., reported 2020-12-30, distributed nationwide. Due to a customer report and internal investigation, it was confirmed that a portion of the affected product l
| Recall number | Z-0720-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2020-12-02 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2023-01-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HR, IE, IL, IN, IR, IT, JP, KE, KR, KW, LT, LV, MX, MY, NL, NO, NZ, OM, PH, PK, PL, PT, QA, RO, SA, SE, SG, SK, TH, TR, TW, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 15099590657550 |
| Model numbers | B1017-216 |
Product
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
Reason for recall
Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.
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-0720-2021. 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.