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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON Systems Phosphorus (PHOSm) Reagent

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 Class 2 Device Recall SYNCHRON Systems Phosphorus (PHOSm) Reagentsee related information
Date Initiated by FirmSeptember 03, 2025
Date PostedOctober 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0071-2026
Recall Event ID 97590
Product Classification Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
ProductSYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Code Information UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactIan Pilcher
714-961-5321
Manufacturer 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.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn September 3, 2025, Beckman Coulter issued a "Urgent Medical Device Recall" Notification to affected consignees via E-Mail. Beckman Coulter asked consignees to take the following actions: 1. You may continue to use the affected lots if calibration passes and quality control results are within your facility s acceptance criteria. 2. If the above lots fail calibration due to INIT ADC HI before the lot expiration date, contact Customer Technical Support Center for troubleshooting and/or replacement. 3. If you receive replacement product, review the Safety Data Sheet (SDS) and discard the affected lot(s). 4. Beckman Coulter offers SYNCHRON Systems Cartridge Chemistry Phosphorus (PHS REF A09426) Reagent as an alternative. 5. Please share this information with your laboratory staff. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 6. Please respond within 10 days.
Quantity in Commerce2146 units
DistributionUS: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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