REPLIGEN CORPORATION: Device Recall
Recall #Z-1024-2026 · 12/10/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1024-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- REPLIGEN CORPORATION
- Status
- Ongoing
- Date Initiated
- 12/10/2025
- Location
- Marlborough, MA, United States
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 33
Reason for Recall
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.
Product Description
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Distribution Pattern
U.S.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.