Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic

FDA Recall Z-0611-2016 · Posted 2016-01-07

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeDAP
Date Initiated2015-11-11
Date Terminated2016-09-23
Product Quantity2647

Reason for Recall

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

Firm Action

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.

Root Cause

Labeling design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare Diagnostics · 2011-05-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑