Stratus(R) CS Rotors, catalog number CROTOR, lot number… recallZ-0343-2011 · Siemens Healthcare Diagnostics, Inc. · initiated Dec 7, 2009
Terminated All recalls posted in November 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0343-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 7, 2009
- Posted by the FDA
- Nov 10, 2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 330 bags
- Product code
- JHX
- FDA submissions
- K984067
- 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 description
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
Code information (models, lots, serial numbers)
catalog number CROTOR, lot number NH42-251-09
Other devices under the same FDA submission
1 device cleared under K984067 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Stratus® CS 10444834Siemens Healthcare Diagnostics Inc. · FLUOROMETRIC METHOD, CPK OR ISOENZYMES71 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page