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BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441...

FDA Recall #Z-0869-2014 — Class II — December 9, 2013

Recall #Z-0869-2014 Date: December 9, 2013 Classification: Class II Status: Terminated

Product Description

BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.

Reason for Recall

Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.

Recalling Firm

Becton Dickinson & Co. — Sparks, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

198 units

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.

Code Information

Catalog number 441385 and 441386

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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