Recall Z-0615-2016— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-0615-2016
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: K060548. Product: Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060. 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

K060548 — STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAKDade Behring, Inc.·cleared 2006-04-06

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 BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060

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.