FDA Medical devices recall ·
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of… recall
- Recall number
- Z-1024-2026
- Date
- (initiated December 10, 2025)
- Company / brand
- Repligen Corporation
111 Locke Dr, Marlborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 33
- Hazard tags
- Fire
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Distribution
U.S.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1024-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.