BD BACTEC FX- Top Unit instrument recall
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration…
Why was BD BACTEC FX- Top Unit 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 441385 and 441386
- Product
- BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration…
- Recalling firm
- Becton Dickinson & Co.
- 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.
- Recall date
- February 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)