Quick Facts at a Glance
- Recall Date
- December 10, 2025
- Hazard Level
- HIGH
- Brand
- REPLIGEN
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- REPLIGEN
- Product type
- Spectrometer
- Model numbers
- PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 10, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact REPLIGEN CORPORATION or your healthcare provider for instructions
About This Product
The Maverick Measurement Module Spectrometer is used in various scientific and medical applications for precise measurements. Consumers purchase this device for its ability to provide accurate data in laboratory settings.
Why This Is Dangerous
A disconnected or improperly crimped cable can lead to a malfunction in the laser system, resulting in unexpectedly high output or unintended activation, which poses a risk of burns or other injuries during use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause significant disruption for professionals relying on this equipment for critical measurements, as it may require immediate cessation of use and the potential for delays in their work.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device to confirm it is PN 820-01367.
- Look for any signs of cable disconnection or poor crimping in the device.
- Review the user manual for recall instructions.
Where to find product info
The model number can be found on the main body of the spectrometer or in the accompanying documentation.
What timeline to expect
Expect a processing timeline of approximately 4-6 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Document all correspondence attempts with REPLIGEN.
- Reach out to consumer safety organizations for additional support.
How to prevent similar issues
- Always verify that medical devices have undergone safety testing before purchase.
- Check for up-to-date recalls on devices you own regularly.
- Ensure proper handling and storage of devices to prevent mechanical stress.
Documentation advice
Keep records of your purchase, including receipts and any correspondence related to the recall.
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Product Details
The recalled product is the Maverick Measurement Module Spectrometer, model PN 820-01367, originally part of kit PN 820-01519, with finished goods number PN 820-01496. The recall affects a total of 33 units distributed in the U.S.
Key Facts
- Affected model: PN 820-01367
- Risk of elevated laser output
- Potential unintended laser firing
- Contact REPLIGEN for instructions
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