Spectrometer modules recalled over elevated laser output and unintended firing
Repligen is recalling 33 MAVERICK Measurement Module Spectrometers because cable faults can drive laser output to about 1,600 mW or falsely signal a fire command.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm describes elevated laser output and unintended laser firing, and no injuries are reported.
Plain-English summary
The MAVERICK Measurement Module Spectrometer, PN 820-01367, originally part of kit PN 820-01519 and carrying finished goods PN 820-01496, is being recalled by Repligen Corporation.
The record describes two faults. For potential elevated laser output, a disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact, and at one connection on the board the failure can drive the laser output to approximately 1,600 mW. For potential unintended laser firing, a disconnected or poorly crimped cable can falsely signal a fire command during measurement cycles, and at a secondary location on the board this fault can lead to unexpected laser activation during operation. The record states safety logic prevents firing when the system is idle.
The record lists 33 units. Distribution was in the U.S. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Users should follow Repligen's instructions.
The recalled product
- Product
- PEPTO BISMOL 32CT
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Medical Device — Spectrometer
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry distributed by Gold Star Distribution.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 27 recalled by GOLD STAR DISTRIBUTION INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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