Medical device recalls Moderate risk

MAVERICK¿ Measurement Module Spectrometer PN Finished Goods PN recalled over fire hazard

Recall date
December 10, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
REPLIGEN CORPORATION recalls MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01…
Recall number
Z-1024-2026
FDA classification
Class II
Brand / firm
REPLIGEN CORPORATION
Sold / distributed
U.S.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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