Recall Z-0343-2011 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
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
| Date | Nov 10, 2010 (initiated Dec 7, 2009) |
| Status | Terminated |
| Reason | Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation. |
| 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984067 | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK Dade Behring, Inc., Jan 13, 1999 |