VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial sus...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3075-2017.
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3075-2017.
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-3075-2017.
Biomerieux Inc
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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.
Biomerieux Inc Recall FAQ
Biomerieux Inc is the subject of a diagnostic devices safety report: VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial sus.... The notice was published on July 12, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 1,866 units are potentially affected.