Recalls / —

—#141558

Product

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

FDA product code

DDR — Myoglobin, Antigen, Antiserum, Control

Device class

Class 2

Medical specialty

Immunology

510(k) numbers

K051650

Affected lot / code info

Lot Numbers: 815131002, 815222002

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 #141558. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.