Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is
FDA device recall Z-0429-2013 · posted 2012-11-21 · Terminated
Recall details
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JPK
- Quantity affected
- 22,954
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-09-14
- Date posted
- 2012-11-21
- Date terminated
- 2013-04-22
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL (K850755) | R&D Systems, Inc. | 1985-05-13 |
| CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE (K843962) | R&D Systems, Inc. | 1984-11-01 |