• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall PhoenixSpec Calibrator & Kit

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 3 Device Recall PhoenixSpec Calibrator & Kit see related information
Date Initiated by Firm June 01, 2016
Create Date October 25, 2016
Recall Status1 Terminated 3 on November 08, 2016
Recall Number Z-0311-2017
Recall Event ID 75375
510(K)Number K023301  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.

Code Information Part/Catalog Number.: 440911, 441951  Lot / Serial Number. :5364776, 5345796 
Recalling Firm/
Becton Dickinson & Co.
7 Loveton Cir
BD Diagnostic Systems
Sparks MD 21152-9212
For Additional Information Contact
Manufacturer Reason
for Recall
BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.
FDA Determined
Cause 2
Process control
Action All US customers were contacted via letters sent via UPS. Ex-US BD sites will contact customers in their local regions. The firm will use an acknowledgement form included with the follow up letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement
Quantity in Commerce 20
Distribution BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers. US: AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI. Ex-US: Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand and Vietnam 4 US government sites were contacted
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LON and Original Applicant = BECTON DICKINSON & CO.