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BD BACTEC FX- Top Unit instrument, catalog number 441385… recallZ-0869-2014 · Becton Dickinson & Co. · initiated Dec 9, 2013

Class II Terminated All recalls posted in January 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

BD Diagnostics initiated a field correction by phone on December 9, 2013, to affected customers and followed the calls with letters, e-mails, or fax. BD Diagnostics sent a secondary Urgent Field Corrective Action letter dated November 2013 to all affected customers. The recalling firm Secondary notifications were serial number specific and explained that some BD BACTEC FX instruments contain racks that may demonstrate variable indicator light intensities. Specifically, the Anonymous vial indicator lights which should appear yellow may instead appear more green in color. BD noted that affected instruments continue to function properly and will not report an incorrect result. The issue is limited to the yellow indicator lights only. Red and green indicator lights appear as intended. BD is developing software to correct this issue and anticipates that the new software will be available to begin instrument updates by February, 2014. The new software will not affect instrument if the indicator lights are functioning as intended. Until the software can be updated on your instrument, BD provided workflow instructions to ensure that the indicator light issue does not occur. For questions regarding this recall call 410-316-4054.

Recall details

Recall number
Z-0869-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 9, 2013
Posted by the FDA
Jan 30, 2014
Recalling firm
Becton Dickinson & Co.
Quantity
198 units
Product code
MDB
FDA submissions
K915796
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.

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.

Code information (models, lots, serial numbers)

Catalog number 441385 and 441386

Other devices under the same FDA submission

6 devices cleared under K915796 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 67245).

Sources and updates

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