ADVIA Chemistry Systems Drug Calibrator I — Class II medical device recall Z-1321-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-04-01, distributed nationwide. Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for t
| Recall number | Z-1321-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2015-01-19 |
| Classified | 2015-03-25 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2015-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 657 |
| Lot numbers | 3JD018 |
| Expiration dates | 2015-04-20 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1321-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.