Z-0869-2014 Class II Terminated
FDA device recall Z-0869-2014 was initiated by Becton Dickinson & Co. on Dec 9, 2013 and is designated Class II. Reason for recall: Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens. The recall status is terminated (terminated Aug 20, 2014). Affected quantity: 198 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 5, 2014
- Initiation Date
- Dec 9, 2013
- Termination Date
- Aug 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198 units
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.
Distribution Pattern
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0869-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026