Recall Z-2407-2010 ยท MLM Enzyme Immunoassay, Tracrolimus
Siemens Healthcare Diagnostics, Inc.
Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.
| Date | Sep 13, 2010 (initiated Jun 15, 2010) |
| Status | Terminated |
| Reason | Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result. |
| Root cause | Other |
| Action | Siemens issued an "Urgent Field Safety Notice" dated June, 2010 to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the TACR Flex reagent lots DC0306, CA0320, DA0334 and GA0348. The letter contains the following instructions: 1) Immediately discontinue use of the affected lots; 2) Discard all remaining inventory of the affected lots; 3) Contact Siemens Healthcare Diagnostics Technical Solutions Center for replacement product; 4) Complete and return the Field Correction Effectiveness Check by fax to 302 631-8467; 4) Si |
| Quantity | 4580 Cartons |
| Distribution | Worldwide Distribution to USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, LA, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI, and countries of Austria, Belgium, Canary Islands, Egypt, France, Germany, Great Britain, Hungary, Italy, The Netherland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060502 | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 Dade Behring, Inc., May 18, 2006 |