Recall Z-2324-2009 ยท JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Trek Diagnostic Systems
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.
| Date | Sep 30, 2009 (initiated Jun 4, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 31 boxes/10/11 ml tubes |
| Distribution | Nationwide Distribution -- PA, VA & WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K860753 | SENSITITRE SUSCEPTIBILITY PLATES Gibco Laboratories Life Technologies, Inc., May 6, 1986 |