Z-0343-2011

Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09

Name: Z-0343-2011 Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-12-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-12-07 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2009-12-07. The reason FDA records is "Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0343-2011
Status: Terminated
Initiated: 2009-12-07
Posted: 2010-11-10
Terminated: 2010-11-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: JHX Fluorometric Method, Cpk Or Isoenzymes
Reason for recall: Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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
Product codes and lots: catalog number CROTOR, lot number NH42-251-09

Product code JHX

K984067Class IIStratus (R) Cs Stat Fluorometric Analyzer, Stratus (R) Cs Ckmb Test PakDade Behring, Inc. / cleared 1999-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)