FDA-Device2026-01-21Class IIPROCESSING DEFECT

Repligen MAVERICK Measurement Module Spectrometer recalled for elevated laser output and unintended firing risk

BURNELECTRICAL SHOCKOTHERNationwide distribution

Stop using Repligen MAVERICK Spectrometer

Repligen is recalling the MAVERICK Measurement Module Spectrometer due to cable connection defects that can cause two problems: the laser output may increase to unsafe levels, or the laser may fire unexpectedly during normal operation. A loose or poorly crimped cable under stress can trigger these faults. No injuries have been reported.

Stop using the affected spectrometer immediately
Check if your device matches part number 820-01367, 820-01519, or 820-01496
Contact Repligen Corporation for instructions on return or repair
Do not attempt to repair or operate the device yourself

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

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-1024-2026

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