FDA Medical devices recall ·
SYNCHRON Systems Phosphorus (PHOSm) Reagent recall
- Recall number
- Z-0071-2026
- Date
- (initiated September 3, 2025)
- Company / brand
- Beckman Coulter, Inc.
250 S Kraemer Blvd, Brea, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2146 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278
Distribution
US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
States: Kentucky Maryland Mississippi North Carolina Nebraska New Jersey New York Texas Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0071-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.