MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Recalling Firm: REPLIGEN CORPORATION
Motivo del Retiro / Peligro
TranslatedPotential 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.
Descripción del Producto e Identificación
TranslatedMAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 98260 |
| Address 1 | 111 Locke Dr |
| Code info | PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496 |
| Postal code | 01752-7236 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 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. |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20251210 |
| Center classification date | 20260113 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableREPLIGEN CORPORATION
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionU.S.
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🚨 SAFETY ALERT: REPLIGEN CORPORATION - MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496 Check if your household is affected: https://therecallfile.com/es/recalls/maverick-measurement-module-spectrometer-pn-820-01367-originally-part/FDA-Z-1024-2026
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