ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 20
FDA device recall Z-0289-2013 · posted 2012-11-14 · Terminated
Recall details
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Reason for recall
- This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay.
- Action taken
- HORIBA Medical sent customer communication letters dated October 24, 2011, to all affected customers via Fax with the exception of two communications that were emailed. The response or confirmation of receipt was conducted via telephone and also documented on attached Notification List. Customers were given a list of procedures to follow and asked to complete and fax the Acknowledgement of Receipt Form to +33 (0)4 67 14 15 17. For questions regarding this recall call 949-453-0500, ext 208.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CGX
- Quantity affected
- 8,503 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-09-14
- Date posted
- 2012-11-14
- Date terminated
- 2012-11-29
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H (K072115) | Horiba Abx | 2007-11-30 |