Recall Z-1599-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1599-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-14

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-02-14, terminated 2024-02-22. It names one FDA 510(k) clearance: K071811. Product: Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.. Reason: The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-02-14
Terminated: 2024-02-22
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K071811 — ETOH FLEX REAGENT CARTRIDGE (DF22)Dade Behring, Inc.·cleared 2007-08-24

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

Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

Reason for recall

The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.

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