Siemens Healthcare Diagnostics, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
catalog number CROTOR, lot number NH42-251-09
Products Sold
catalog number CROTOR, lot number NH42-251-09
Siemens Healthcare Diagnostics, Inc. is recalling Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus(R) rotors due to Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, AZ, AR, CA, FL, GA, HI, IL, IN, IA, KY, LA, MI, MN, MS, MO, MT, NH, NM, NY, NC, ND, OH, TX, UT, WA, WV, WI
Page updated: Jan 10, 2026