Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus(R) rotors is intended for the

FDA device recall Z-0343-2011 · posted 2010-11-10 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

JHX

Quantity affected

330 bags

Distribution

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

Date initiated

2009-12-07

Date posted

2010-11-10

Date terminated

2010-11-10

Location

Newark, DE

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