—#141555

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

FDA product code: DHA — System, Test, Human Chorionic Gonadotropin
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K060548
Affected lot / code info: Lot Numbers: 445146002, 445201002, 445243002

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on November 11, 2015 both in the United States and internationally for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding call 781-269-3000.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc
Address: 2 Edgewater Dr, Norwood, Massachusetts 02062-4637

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

Timeline

Recall initiated: 2015-11-11
Posted by FDA: 2016-01-07
Terminated: 2016-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.