Recall Z-0468-2016— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0468-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-19

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-11-19, terminated 2017-08-15. It names one FDA 510(k) clearance: K884544. 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: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-19
Terminated: 2017-08-15
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K884544 — DADE FACTOR VIII CHROMOGENIC ASSAYBaxter Healthcare Corp·cleared 1988-12-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.