Z-1321-2015Class II

ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2...

Name: Z-1321-2015 ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-01-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-01-19 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2015-01-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1321-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-19
Posted: 2015-03-25
Terminated: 2015-09-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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 batch modes for in vitro diagnostic use. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: design
FDA 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 to contact their local Siemens technical support representative. For questions regarding this recall call 914-631-8000.
Quantity in commerce: 657
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico.
Product codes and lots: Material Number 10376770, Lot Number 3JD018, Expiration: April 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1321-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1321-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-25

Product code JIX

K093732Class IIAdvia Chemistry Drug Calibrator I Model 10376770Siemens Healthcare Diagnostics / cleared 2010-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)