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U.S. Department of Health and Human Services

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

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  Class 3 Device Recall Sensititre MuellerHinton Broth w/Lysed Horse Blood see related information
Date Initiated by Firm June 04, 2009
Date Posted September 30, 2009
Recall Status1 Terminated 3 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 2
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 and Original Applicant = GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
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