Medical Device Recall: Z-0028-2014

FDA Recalls dataset · Firm: Becton Dickinson & Co. BD Diagnostic Systems · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-09-09 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-2014.

Recall Res Number
Z-0028-2014
Recalling Firm / Manufacturer
Becton Dickinson & Co. BD Diagnostic Systems
FEI Number
1119779
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-09-09
Date Posted
2013-10-19
Date Terminated
2013-10-29
Product Code
MDB
Event Number
66325
Product Quantity
187,000 tubes
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.
Action Details BD sent an Urgent Product Recall letter dated September 2013 to customers identified as microbiology lab managers. The letter identified the affected product, problem and actions to be taken. The letter advised that referenced lot numbers may contain an overlabel barcode that may begin to lift, exposing the original incorrect barcode pictured in the notification. Customers were instructed to complete the attached form and fax to Regulatory Compliance 410-316-4258. For further assistance regarding replacements contact BD Customer Service Department at 1-800-675-0908 and all other inquiries contact BD Technical Services Department at 1-800-638-8663.
Distribution Pattern USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI
Code Information / Serial Numbers Lot Number/ Exp. Date  3070436 September 12, 2014 3042466 August 16, 2014 3053239 August 30, 2014 3053240 August 30, 2014 3061013 September 6, 2014 3061014 September 6, 2014 3070433 September 12, 2014 3070437 September 12 , 2014

Related Establishments / Registrations

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