Reported Oct 15, 2025 · Ongoing
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- SYNCHRON
- Systems Phosphorus (PHOSm) Reagent REF467868 For In Vitro Diagnostic Use, Rx Only
- Lot codes and dates
- UDI15099590233358/
- Lot Numbers
M309642M309641M401490M404365M406380M406417M408408M410466M410513M412278
- Amount recalled
- 2146 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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