Class II U.S. Food and Drug Administration

Beckman Coulter Inc. Synchron Systems Phosphorus Reagent REF: 467868 For In Vitro recall: Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868)

Recall published 1+ years ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0071-2026
Published
October 15, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Beckman Coulter Inc.
Product type
Medical devices
Units affected
2146 units
Distribution
Alabama, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Washington, West Virginia
Made in
United States
Lot / code info
UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278
UPC codes
15099590233358

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 15099590233358

Model or item number

On the rating label, the box or the instruction sheet.

  • Rx Only. — UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Beckman Coulter Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Beckman Coulter Inc. — 250 S Kraemer Blvd, Brea, CA, 92821-6232

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Beckman Coulter Inc. medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 15099590233358; model number Rx Only. — UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Which states were affected?

The notice lists Alabama, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania and others.

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