Recall Z-1024-2026— REPLIGEN CORPORATION
Class II · Ongoing
Class II FDA medical device recall by REPLIGEN CORPORATION, initiated 2025-12-10. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- REPLIGEN CORPORATION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-10
- Firm location
- Marlborough, MA, United States
Product description
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.