Recall Z-0613-2016— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-0613-2016
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 CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068. 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 CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068

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.