BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The 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.
Reported: February 5, 2014 Initiated: December 9, 2013 #Z-0870-2014
Product Description
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The 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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 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.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The 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.. Recalled by Becton Dickinson & Co.. Units affected: 2 units.
Why was this product recalled? ▼
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0870-2014.
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