Z-0071-2026Class II

SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only

Name: Z-0071-2026 SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only
Creator: Beckman Coulter Inc.
Published: 2025-09-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-09-03 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only on 2025-09-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0071-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-03
Posted: 2025-10-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Product code: CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
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.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: On 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 commerce: 2146 units
Distribution: US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
Product codes and lots: UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0071-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0071-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-08

Product code CEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)