HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
Beckman Coulter Reagents Recalled Due to Calibration Failure
Beckman Coulter recalled 2,146 units of SYNCHRON Systems Phosphorus reagents on September 3, 2025. The affected lots may fail calibration before expiration, delaying patient results. Healthcare providers must stop using the product immediately.
Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Beckman Coulter
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Inc. or your healthcare provider for instructions. Notification method: E-Mail
Product Details
The recalled product is SYNCHRON Systems Phosphorus (PHOSm) Reagent, REF: 467868. It was distributed to various states in the U.S., Canada, Mexico, and Singapore. The affected lot numbers include M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M410513, M412278.
The Hazard
The phosphorus reagent may fail calibration before its expiration date. This failure can lead to delays in obtaining patient results, which poses significant risks in clinical settings.
Reported Incidents
No specific incidents of injury or death have been reported in relation to this recall. The risk associated with delayed results can impact patient care.
What to Do
Stop using the affected reagent immediately. Follow instructions provided by the manufacturer and contact Beckman Coulter Inc. or your healthcare provider for further guidance.
Contact Information
For more information, contact Beckman Coulter Inc. at [insert contact number]. Visit their website for further instructions.
Key Facts
- Recall date: September 3, 2025
- Quantity recalled: 2,146 units
- Affected lot numbers: M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M4105
- Distribution: U.S., Canada, Mexico, Singapore
- Hazard level: High
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeIn Vitro Diagnostic Reagent
Sold At
Multiple Retailers
Product Details
Brand
Categories
Model Numbers
UDI: 15099590233358
Lot Numbers: M309642
M309641
M401490
M404365
+6 more
Affected States
Nationwide
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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