Recall Z-0429-2013 ยท JPK Mixture, Hematology Quality Control
Horiba Instruments, Inc dba Horiba Medical
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, a
| Date | Nov 21, 2012 (initiated Sep 14, 2012) |
| Status | Terminated |
| Reason | HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010. |
| Root cause | Nonconforming Material/Component |
| Action | HORIBA Medical sent a Product Information Notice letter dated November 5, 2010 via Fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the instructions included with the Product Information Notice. For questions customers were instructed to call the Technical Support Hotline at 1-888-903-5001. For questions regarding this recall call 949-453-0500, ext 208. |
| Quantity | 22,954 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |