Recall Z-1486-2018— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1486-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-21

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2018-02-21, terminated 2019-05-16. It names one FDA 510(k) clearance: K020828. Product: ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests). Reason: Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-02-21
Terminated: 2019-05-16
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEMBayer Corp.·cleared 2002-07-24

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

ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)

Reason for recall

Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.

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