—#95089

Product

Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer

FDA product code: JHX — Fluorometric Method, Cpk Or Isoenzymes
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K984067
Affected lot / code info: catalog number CROTOR, lot number NH42-251-09

Why it was recalled

Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.

Root cause (FDA determination)

Process control

Action the firm took

The recalling firm, SIEMENS, issued an "Urgent Field Safety Notice" dated December 2009 to all affected customers. The notice described the product, problem and the action to be taken by the customers. The customers were instructed to review the situation with their laboratory director to determine the need to evaluate previously reported test results; immediately examine their CROTOR inventory and discard all bags that are from lot NH42-251-09 including rotors that were not stored in their original packaging (bag); contact Siemens Customer Service Center at 800-241-0420 to request additional no-charge replacements (Note: A "no-charge" order has already been placed so that one bag of replacement rotors would be recieved shortly); forward this notice to anyone they may have distributed this product, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK via fax at 302-631-8467. If you have any questions regarding this information, please contact the Siemens Technical Solution Center at 800-405-6473.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide distribution: USA including states of AK, AZ, AR, CA, FL, GA, HI, IA, IL, IN, KY, LA, MI, MN, MO, MS, MT, NC, ND, NH, NM, NY, OH, TX, UT, WA, WI, and WV and country of Canada

Timeline

Recall initiated: 2009-12-07
Posted by FDA: 2010-11-10
Terminated: 2010-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95089. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.