Recall Z-0071-2026 ยท CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Beckman Coulter Inc.
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
| Date | Oct 8, 2025 (initiated Sep 3, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | On September 3, 2025, Beckman Coulter issued a "Urgent Medical Device Recall" Notification to affected consignees via E-Mail. Beckman Coulter asked consignees to take the following actions: 1. You may continue to use the affected lots if calibration passes and quality control results are within your facility s acceptance criteria. 2. If the above lots fail calibration due to INIT ADC HI before the lot expiration date, contact Customer Technical Support Center for troubleshooting and/or replacement. 3. If you receive replacement product, review the Safety Data Sheet (SDS) and discard the |
| Quantity | 2146 units |
| Distribution | US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.