Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.

FDA device recall Z-2407-2010 · posted 2010-09-13 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.

Action taken

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) Siemens is recommending that the content of the letter should be discussed with the laboratory director. If unexpectedly low results are obtained on a patient sample, caution should be exercised before decisions regarding therapeutic dosage adjustments are made. As stated in the package insert, "Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. Also individual tacrolimus values cannot be used as the sole indicator for making changes in the treatment regimen. Each patient should be thoroughly evaluated clinically before treatment adjustments are made." Siemens Technical Solutions Center may be contacted at 800-441-9250

Root cause

Other

Status

Terminated

Product code

MLM

Quantity affected

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 Aust

Date initiated

2010-06-15

Date posted

2010-09-13

Date terminated

2010-12-16

Location

Newark, DE

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