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Sensititre AIM™

TREK DIAGNOSTIC SYSTEMS LIMITED · Model V3020 · UDI-DI 05032384497409

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The product trade name is Sensititre AIM™. The product is a microprocessor-controlled automated inoculation delivery system. It is designed to deliver, through a disposable dosing head, multiples of 50 µL inoculum to a Sensititre 96-well microtitration plate for in vitro antimicrobial susceptibility testing and/or identification of pathogenic microorganisms. Sensititre AIM is for professional use only and is not intended for self-testing.The performance of Sensititre AIM to inoculate standard 96-well microtitration plates (non-Sensititre plates) has not been established. Although other brands of 96-well microtitration plates may be used on the AIM instrument, they must be pre-qualified before use.

Recalls

Date	Firm	Reason
2019-12-13	Beckman Coulter Inc.	Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible resul
2006-09-27	Dade Behring, Inc.	Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.