DxC 700 AU — Class II medical device recall Z-1552-2026
Ongoing recall by Beckman Coulter Mishima K.K., reported 2026-03-18, distributed nationwide. A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Micr
| Recall number | Z-1552-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Mishima K.K., Sunto-Gun, N/A, Japan |
| Recall initiated | 2026-01-30 |
| Classified | 2026-03-11 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 142 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 14987666542514, 14987666542545 |
| Model numbers | B86444, B86446 |
Product
DxC 700 AU, REF: B86444, B86446
Reason for recall
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.
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-1552-2026. 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.