ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS — Class II medical device recall Z-1659-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-06-04, distributed nationwide. Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and
| Recall number | Z-1659-2014 |
|---|---|
| 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 | 2014-04-10 |
| Classified | 2014-05-23 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2016-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AT, BE, BG, BH, CH, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IQ, IR, IS, IT, JO, LB, LT, LU, LV, MT, NL, NO, OM, PK, PL, PT, QA, RO, RS, SA, SE, SI, SK, TR |
| Quantity | 16,302 kits |
| Model numbers | 10378883 |
Product
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Reason for recall
Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
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-1659-2014. 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.