Recall Z-1321-2015 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and bat
| Date | Mar 25, 2015 (initiated Jan 19, 2015) |
| Status | Terminated |
| Reason | Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation. |
| Root cause | Device Design |
| Action | Siemens issued an Urgent Medical Device Correction, on/about January 19, 2015, notifying customers about the product, problem, and action to be taken. Customers were instructed to update the calibrator values for Drug Calibrator 1, Lot 3JD018. All customerswere requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within (30) days. Field service personnel have been sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers with questions were instructed |
| Quantity | 657 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093732 | ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 Siemens Healthcare Diagnostics, Mar 22, 2010 |