CLASS II ONGOING Device recall · Reported 15 Oct 2025 · FDA Enforcement Report
Synchron Systems Phosphorus (PHOSm) Reagent recalled by Beckman Coulter
Beckman Coulter is recalling Synchron Systems Phosphorus (PHOSm) Reagent, distributed in 14 states. The recall was initiated on 3 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0071-2026
- FDA event ID
- 97590
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Sep 2025
- FDA classified
- 8 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Sep 2025 | Recall initiated by company | |
| 8 Oct 2025 | Classified by FDA | +35 days |
| 15 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Where it was distributed
US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
AlabamaKentuckyLouisianaMassachusettsMarylandMississippiNorth CarolinaNebraskaNew JerseyNew YorkPennsylvaniaTexasWashingtonWest Virginia
Questions about this recall
Is Synchron Systems Phosphorus (PHOSm) Reagent recalled?
Yes. Beckman Coulter recalled Synchron Systems Phosphorus (PHOSm) Reagent on 3 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0071-2026.
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.
Which lots are affected?
UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278
Where was it sold?
US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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