Appearance & Handling
The test and control cell reagent should appear as a uniform, deep red solution with a characteristic fibrin-like sheen. It must be visually free from any particulates and show no evidence of cell build-up or sedimentation, particularly at the bottom of the vial.
A mechanical rocker may be used to simulate gentle inversion mixing. The reagent must not be vortexed.
Each component of the kit is manufactured separately and assigned its own lot number and expiry date. The overall kit expiry is then determined by the component with the earliest expiry date.
Storage & Sustainability
Reagents must be stored upright at 2–8°C. Do not freeze.
Shipping conditions have been validated for exposure to temperatures between 2°C and 30°C for a maximum duration of 14 days. If this limit is exceeded, please contact QAAdmin@new-bio.com.
No, reagents must never be frozen.
After opening, TPHA and RPR reagents are stable for up to 3 months when stored at 2 – 8°C.
Consumables & Accessories
No.
Shipping & Packaging
Assess the goods for the total amount of damage, place them in quarantine, and store upright at 2–8 °C. Inform NewBio or your local distributor at the earliest opportunity, providing details of the affected goods, including PO number, lot number, quantity and any supporting evidence such as photographs. Each case will be reviewed and assessed on a case-by-case basis.
TiltWatch™ indicators turns red if the shipment has been tilted beyond 80°, providing a visual alert that the package may have been subjected to mishandling.
Please note that a red indicator does not automatically mean the shipment is damaged. Instead, it serves as a prompt to carry out a more thorough inspection of the goods prior to notifying us.
SpotSee WarmMark® temperature indicators, which clearly display brief, moderate, or prolonged exposure above 30° and any exposure below 2°C.
If your SpotSee WarmMark® displays red at any point, please contact us for further guidance. This does not necessarily mean the product cannot be used, but we will help assess whether it remains within acceptable conditions.
Technical Support & Complaints
Unless otherwise defined in a bespoke supply agreement, the standard timeframe for reporting product issues is 14 calendar days from receipt.
If no specific agreement is in place with NewBio, the general Terms & Conditions of Sale apply and can be accessed here: Terms and conditions of sale – Newmarket Biomedical
Any technical queries or complaints should be directed to QAAdmin@new-bio.com
Certificates of analysis can be accessed on the website here: Certificates of Analysis – Newmarket Biomedical.
They can also be provided on request by emailing QAAdmin@new-bio.com.
NewBio ISO certificates can be found on the website here: Quality & Accreditations – Newmarket Biomedical
They can also be provided on request by emailing QAAdmin@new-bio.com
IFU’s can be found on the website here: Quality & Accreditations – Newmarket Biomedical
They can also be provided on request by emailing QAAdmin@new-bio.com
