REPLIGEN CORPORATION
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →