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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Tacrolimus Flex reagent cartridge

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 Class 2 Device Recall Dimension Tacrolimus Flex reagent cartridgesee related information
Date Initiated by FirmMay 07, 2026
Date PostedJune 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2398-2026
Recall Event ID 98985
510(K)NumberK150168 
Product Classification Enzyme immunoassay, tracrolimus - Product Code MLM
ProductSiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Code Information Manufacturing Lot/Serial Numbers: FA6254, FA6260, FA6286; UDIs: (01)00842768035425(10)FA6254(17)20260911; (01)00842768035425(10)FA6260(17)20260917; (01)00842768035425(10)FA6286(17)20261013.
FEI Number 2517506
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information ContactCustomer Care Center
800-275-7795
Manufacturer Reason
for Recall		A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
FDA Determined
Cause 2		Under Investigation by firm
ActionSiemens Healthineers issued an Urgent Medical Device Correction notice to its consignees on 5/12/2026 via FedEx. The notice described the issue, its impact to QC and patient results, and requested the following: "Customer Actions . Immediately discontinue use of and discard the affected kit lot numbers. . Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. . Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for required regulatory reporting. . Complete and return the Field Correction Effectiveness Check Form attached to this letter within (30) days. . Please retain this letter with your laboratory records and forward it to anyone who may have received or used this product." For questions, contact your Siemens Healthineers Customer Care Center at (312) 275-7795 or your local Siemens Healthineers technical support representative.
Quantity in Commerce2878 units
DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi Arabia, Spain, South Africa, Sri Lanka, Turkey, United Arab Emirates.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MLM
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