Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Summary
The FDA issued a Class II for Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107007 by Siemens Healthcare Diagnostics, Inc.. Reason: A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge..
Details
Source
Device Recall
External ID
Z-2398-2026
Action Date
2026-06-17
Status
Ongoing
Category
device
Product Description
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Lot/Code Info: 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.
Quantity Affected: 2878 units
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.
Distribution
Worldwide 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-07
Company
Newark, DE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 228 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2398-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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