MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-014
Summary
The FDA issued a Class II for MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit by REPLIGEN CORPORATION. Reason: Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. A.
Details
Source
Device Recall
External ID
Z-1024-2026
Action Date
2026-01-21
Status
Ongoing
Category
device
Product Description
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Lot/Code Info: PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Quantity Affected: 33
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.
Distribution
U.S.
Type: FDA Mandated
Recall Initiated: 2025-12-10
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (REPLIGEN CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does REPLIGEN CORPORATION have FDA actions?
This is the only FDA action we have on record for REPLIGEN CORPORATION in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1024-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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