Recall Z-0429-2013— Horiba Instruments, Inc dba Horiba Medical
Class III · Terminated
Class III FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2012-09-14, terminated 2013-04-22. It names 2 FDA 510(k) clearances: K850755, K843962. Product: 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: 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..
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-09-14
- Terminated
- 2013-04-22
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K850755 — CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
- K843962 — CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.