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RecallWatchMedical Device Safety
Class IIOngoingZ-1024-2026

REPLIGEN CORPORATION recalls MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820…

REPLIGEN CORPORATIONMarlborough, MA, United StatesReported Jan 21, 2026 · 5 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Lot / code information

Part / Item #
of a kit PN 820-01519) Finished Goods PN 820-01496

What the firm is doing

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.

DistributionShow details

U.S.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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