ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), P
FDA device recall Z-1321-2015 · posted 2015-03-25 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- 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 to contact their local Siemens technical support representative. For questions regarding this recall call 914-631-8000.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 657
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico.
- Date initiated
- 2015-01-19
- Date posted
- 2015-03-25
- Date terminated
- 2015-09-21
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 (K093732) | Siemens Healthcare Diagnostics | 2010-03-22 |