FDAClass IIFebruary 5, 2014

BD BACTEC FX 40 instrument recall

BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is…

Why was BD BACTEC FX 40 instrument recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog number 442296

Product
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is…
Recalling firm
Becton Dickinson & Co.
Quantity
2 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.
Recall date
February 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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