Factor VIII Chromogenic Assay — Class II medical device recall Z-0468-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-12-30, distributed in MA. Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for m
| Recall number | Z-0468-2016 |
|---|---|
| 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 | 2015-11-19 |
| Classified | 2015-12-22 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-08-15 |
| Distributed | MA |
| Countries outside the US | AT, CZ, DE, ES, FR, HU, IT, PL, RS, SE |
| Reason classes | potency |
| Lot numbers | 44637 |
| Model numbers | B4238-40 |
| Expiration dates | 2016-11-30 |
Product
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
Reason for recall
Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay.
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-0468-2016. 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.