Z-1024-2026Class II

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

Name: Z-1024-2026 MAVERICK Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods...
Creator: Repligen Corporation
Published: 2025-12-10
License: https://open.fda.gov/license/

Repligen Corporation / initiated 2025-12-10 / Open, Classified

FDA source

REPLIGEN CORPORATION began a recall of MAVERICK Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496 on 2025-12-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1024-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-10
Posted: 2026-01-13
Recalling firm: Repligen Corporation
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 33
Distribution: U.S.
Product codes and lots: PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1024-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1024-2026	Class II	Ongoing	FDA Mandated	2026-01-21	2026-01-13

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)