RecallRadar

FDA Device recall Z-1024-2026

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

On 2026-01-21 the FDA classified a Class II recall of MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496 by Repligen, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1024-2026
ClassificationClass II
Statusongoing
Initiated2025-12-10
Published2026-01-21
Last updated2026-09-13 11:58 UTC
CompanyRepligen
Distributionn/a

Product

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.

Identifiers

code_infoPN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1024-2026%22

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