CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report
Maverick¿ Measurement Module Spectrometer PN recalled by Repligen
Repligen is recalling Maverick¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN. The recall was initiated on 10 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1024-2026
- FDA event ID
- 98260
- Recalling firm
- Repligen, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Dec 2025
- FDA classified
- 13 Jan 2026
- Reported
- 21 Jan 2026
- Type
- FDA Mandated
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Dec 2025 | Recall initiated by company | |
| 13 Jan 2026 | Classified by FDA | +34 days |
| 21 Jan 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Where it was distributed
U.S.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Where was it sold?
U.S.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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