FDA-Device2026-01-21Class II
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
REPLIGEN CORPORATION
Hazard
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.
Sold states
U.S.
Affected count
33
Manufactured in
111 Locke Dr, Marlborough, MA, United States
Products
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1024-2026Don't want to check this manually?
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