SYNCHRON Systems Phosphorus — Class II medical device recall Z-0071-2026
Ongoing recall by Beckman Coulter Inc., reported 2025-10-15, distributed in AL, KY, LA, MA, MD, MS, NC, NE…. Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration be
| Recall number | Z-0071-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-09-03 |
| Classified | 2025-10-08 |
| Reported by FDA | 2025-10-15 |
| Distributed | AL, KY, LA, MA, MD, MS, NC, NE, NJ, NY, OK, PA, TX, WA, WV |
| Countries outside the US | CA, MX, SG |
| Quantity | 2,146 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 15099590233358 |
| Lot numbers | M309641, M309642, M401490, M404365, M406380, M406417, M408408, M410466, M410513, M412278 |
| Model numbers | 467868 |
Product
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Reason for recall
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
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-0071-2026. 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.