V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer,...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0038-2020.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0038-2020.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0038-2020.
Vital Scientific N.V.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Vital Scientific N.v. Recall FAQ
Vital Scientific N.v. is the subject of a diagnostic devices safety report: V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer,.... The notice was published on September 7, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 192 units are potentially affected.