Class 3 Device Recall Sensititre MuellerHinton Broth w/Lysed Horse Blood

• Date Initiated by Firm: June 04, 2009
• Date Posted: September 30, 2009
• Recall Status: Terminated on February 26, 2010
• Recall Number: Z-2324-2009
• Recall Event ID: 52813
• 510(K)Number: K860753
• Product Classification: Culture Media for Antimicrobial Susceptibility Tests - Product Code JTZ
• Product: Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.
• Code Information: Lot number 150444SA
• Recalling Firm/ Manufacturer: Trek Diagnostic Systems; 982 Keynote Cir Ste 6; Cleveland OH 44131-1873
• For Additional Information Contact: 216-351-8735
• Manufacturer Reason for Recall: Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.
• FDA Determined Cause: Employee error
• Action: On 6/4/2009 each customer was telephoned and instructed to immediately return the recall lot back to the firm. Replacement product was shipped.
• Quantity in Commerce: 31 boxes/10/11 ml tubes
• Distribution: Nationwide Distribution -- PA, VA & WA.
• 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 = JTZ