REPLIGEN CORPORATION: MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- REPLIGEN CORPORATION
- Product
- MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S.
- Recall initiated
- 2025-12-10
- Code info
- PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
- Product quantity
- 33
- Voluntary mandated
- FDA Mandated
- City
- Marlborough
- State
- MA
- Country
- United States
- Event id
- 98260
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