FDAHealthSeptember 3, 2025
Beckman Coulter Inc. — SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
⚠️ 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.
Is this relevant to me?
- Geography
- US, AL, KY, LA, MA, MD, MS, NC, NE, NJ, NY, OK, PA, TX, WA, WV
- Source agency
- FDA
- Category
- Health
- Published
- September 3, 2025
US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
What's affected?
- Product
- SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
- Brand
- Beckman Coulter Inc.
- Lot code
- M309642
Additional details
UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2146 units.
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