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U.S. Department of Health and Human Services

Class 3 Device Recall ROTEM sigma complete

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 Class 3 Device Recall ROTEM sigma completesee related information
Date Initiated by FirmOctober 08, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0439-2027
Recall Event ID 100121
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
ProductROTEM sigma complete; Model/Catalog Number: 555501; In vitro diagnostic to monitor and analyze patient coagulation status from a blood sample.
Code Information Model/Catalog Number: 555501; UDI: 04260160470310; Lot number: S260605;
FEI Number 3005792925
Recalling Firm/
Manufacturer		 TEM INNOVATIONS GMBH
Martin-kollar-str. 13
Munich Germany
Manufacturer Reason
for Recall		Customer ordered US-approved version of the device but received a variant not approved for sale/use in the United States. Product was distributed into an unauthorized geography due to a fulfillment/distribution error.
FDA Determined
Cause 2		Process control
ActionOn October 8, 2026, Medical Device Recall letters were sent to customers. Actions to be taken: 1. Do not use this cartridge kit. 2. Scrap the cartridge kit received. 3. Forward this notification to all affected locations within your facility, if needed. 4. Retain a copy of this notification for your records.
Quantity in Commerce1
DistributionProduct in scope of this recall is for one USA customer located in Hawaii.
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.
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