Recall Z-0028-2014— Becton Dickinson & Co.

Name: FDA recall Z-0028-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-09

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2013-09-09, terminated 2013-10-29. It names one FDA 510(k) clearance: K974883. Product: BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).. Reason: An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2013-09-09
Terminated: 2013-10-29
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K974883 — BACTEC MGIT 960 SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1998-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

Reason for recall

An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.

Data sourced from openFDA. This site is unofficial and independent of the FDA.