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Recall Observatory FDA recall evidence

Device product

MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Z-1024-2026

December 10, 2025

Class II

Product summary

Firm
REPLIGEN CORPORATION
Event
Event 98260
Status
Ongoing
Classification
Class II
Quantity
33
Official record key
device-enforcement:Z-1024-2026

Official wording

Reason: 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.

Code information: PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Distribution pattern: U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.