Z-0071-2026 Class II Ongoing
FDA device recall Z-0071-2026 was initiated by Beckman Coulter Inc. on September 3, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2146 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- September 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2146 units
Product Description
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.
Distribution Pattern
US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
Code Information
UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278