MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Fi...
FDA Recall #Z-1024-2026 — Class II — December 10, 2025
Product Description
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
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.
Recalling Firm
REPLIGEN CORPORATION — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
33
Distribution
U.S.
Code Information
PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Status
Ongoing
Voluntary / Mandated
FDA Mandated