FDA Recall Open, Classified

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

Recall: Z-1024-2026 · Initiated December 10, 2025

Recall

Recall Number
Z-1024-2026
Event Number
98260
Firm
REPLIGEN CORPORATION
FEI Number
3015685946
Status
Open, Classified
Root Cause
Radiation Control for Health and Safety Act
Initiated
December 10, 2025
Posted
January 13, 2026
Address
111 Locke Dr, Marlborough, MA, 01752-7236

Description

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

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.

Action

Repligen will repair the connections in each potentially affected MAVERICK device. In the meantime, all customers have been instructed to refrain from using the device.

Distribution

U.S.

Quantity

33