ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy
FDA device recall Z-0904-2014 · posted 2014-01-31 · Terminated
Recall details
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Reason for recall
- Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
- Action taken
- Horiba sent an customer notification letter dated November 32, 2013, to all affected customers. The letter was sent via email to all customers who purchased the ABX PENTRA 400. HORIBA Medical is informing all ABX PENTRA N Control customers running the Potassium-E assay on the ABX PENTRA 400 with I.S.E. Module that the Target Value and Target Range for Potassium has been updated. The letter informs the customers of the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days by fax (949) 453-0600 Customers with questions are instructed to contact their local HORIBA Medical representative. For further questions please call (949) 453-0500 X 208
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JJY
- Quantity affected
- 698 units total (80 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide)
- Date initiated
- 2013-11-21
- Date posted
- 2014-01-31
- Date terminated
- 2014-10-28
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) (K052007) | Horiba Abx | 2005-12-16 |