MAVERICK¿ Measurement Module Spectrometer PN 820-01367 — Class II medical device recall Z-1024-2026
Ongoing recall by REPLIGEN CORPORATION, reported 2026-01-21. Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress
| Recall number | Z-1024-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | REPLIGEN CORPORATION, Marlborough, MA, United States |
| Recall initiated | 2025-12-10 |
| Classified | 2026-01-13 |
| Reported by FDA | 2026-01-21 |
| Quantity | 33 |
| Model numbers | 820-01519 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1024-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.