ADVIA Centaur¿ Systems Phenytoin Calibrator N — Class II medical device recall Z-0930-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-02-12, distributed nationwide. ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVI
| Recall number | Z-0930-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2013-12-18 |
| Classified | 2014-02-04 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2016-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CN, EC, EG, IN, JP, KR, MX, SG, TH, UY |
| Reason classes | potency |
| Lot numbers | 18998A58, 21854A58, 25487A59 |
Product
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Reason for recall
ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.
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-0930-2014. 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.