FDA recall, , Moderate risk
Repligen Maverick Measurement Module Spectrometer
The Maverick Measurement Module Spectrometer can have elevated laser output or unintended laser firing due to cable issues.
Summary by Recall Canary from the FDA notice
What happened
REPLIGEN CORPORATION of Marlborough, Massachusetts began a recall on December 10, 2025, of the MAVERICK Measurement Module Spectrometer PN 820-01367, originally part of kit PN 820-01519, and Finished Goods PN 820-01496. A disconnected or poorly crimped cable under mechanical bending stress can cause loss of electrical contact, potentially driving the laser output to approximately 1,600 mW at one connection on the board, and can falsely signal a fire command during measurement cycles.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
- Affected units
- PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Recall details
- Company began the recall
- Sold in
U.S.
- Company
- REPLIGEN CORPORATIONMarlborough, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98260
- Recall number
- Z-1024-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
