Z-0429-2013 Class III Terminated
FDA device recall Z-0429-2013 was initiated by Horiba Instruments, Inc dba Horiba Medical on September 14, 2012 and is designated Class III. Reason for recall: 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 communic… The recall status is terminated (terminated April 22, 2013). Affected quantity: 22,954.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- September 14, 2012
- Termination Date
- April 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,954
Product Description
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, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagents
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution
Code Information
Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).