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.
FDA Recall Z-2324-2009 · Posted 2009-09-30
Advertisement
Recalling FirmTrek Diagnostic Systems
Recall StatusTerminated
Product CodeJTZ
Date Initiated2009-06-04
Date Terminated2010-02-26
Product Quantity31 boxes/10/11 ml tubes
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution -- PA, VA & WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement