Class 2 Device Recall MAVERICK

• Date Initiated by Firm: December 10, 2025
• Date Posted: January 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1024-2026
• Recall Event ID: 98260
• Product: MAVERICK Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
• Code Information: PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
• FEI Number: 3015685946
• Recalling Firm/ Manufacturer: REPLIGEN CORPORATION; 111 Locke Dr; Marlborough MA 01752-7236
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• 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.
• Quantity in Commerce: 33
• Distribution: U.S.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.