Vital Scientific recalls V-Twin diagnostic devices with serial numbers 14-3301-14-3344, 15-3301-15-3326, 16-3301-16-3353, 17-3301-17-3346, 18-3301-18-3323 due to improper cooling indicator installation that may cause reagent storage issues.
The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.
Vital Scientific is recalling V-Twin diagnostic devices with specific serial numbers because the cooling indicator board was installed incorrectly. This could lead to the device failing to warn users if reagent cooling fails, potentially causing reagent storage conditions to become unsafe.
The cooling indicator board was improperly installed, so if reagent cooling fails, the device won't alert the user with a light or sound. This means the reagent storage conditions could become unsafe, potentially affecting test accuracy or results.
Healthcare professionals using the V-Twin diagnostic devices for clinical testing are most at risk. The affected devices have specific serial numbers listed in the recall notice.
Check for the V-Twin device with serial numbers: 14-3301-14-3344, 15-3301-15-3326, 16-3301-16-3353, 17-3301-17-3346, or 18-3301-18-3323. The device is an in vitro diagnostic chemistry analyzer used in clinical settings.
Identify the serial number on your V-Twin device to confirm if it is in the recall list.
The cooling indicator board was improperly installed, which could cause the device to fail to warn users if reagent cooling fails, potentially leading to unsafe reagent storage conditions.
Check the serial number against the list provided in the recall notice to see if your device is affected. If it is, contact Vital Scientific for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Vital Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0038-2020 — Vital Scientific Vital Scientific Hello, I own a Vital Scientific that is covered by recall Z-0038-2020 from Vital Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
