Recall Z-0618-2016— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-0618-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-11

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2015-11-11, terminated 2016-09-23. It names one FDA 510(k) clearance: K051650. Product: Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic. Reason: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems.

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2015-11-11
Terminated: 2016-09-23
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.·cleared 2005-09-08

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

Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

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