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U.S. Department of Health and Human Services

Class 2 Device Recall TEG 5000 Functional Fibrinogen Reagent

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  Class 2 Device Recall TEG 5000 Functional Fibrinogen Reagent see related information
Date Initiated by Firm April 26, 2022
Create Date June 30, 2022
Recall Status1 Terminated 3 on March 15, 2024
Recall Number Z-1310-2022
Recall Event ID 90323
510(K)Number K002177  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Code Information UDI-DI: (01)20812747018095  All lots are affected.
Recalling Firm/
Manufacturer		 Haemonetics Corporation
125 Summer St
Boston MA 02110-1616
For Additional Information Contact Customer Support, Haemonetics
800-537-2802
Manufacturer Reason
for Recall		 Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
FDA Determined
Cause 2		 Other
Action On April 26, 2022, affected customers were provided with a recall letter via email. Customers may continue to use the TEG 5000 Functional Fibrinogen reagent with the current IFU in conjunction with the letter which reflects the updated ranges. Haemonetics will provide a revision to the IFU. Additionally, customers using Functional Fibrinogen reagent are being reminded to continue to follow the instructions in the current Instructions for Use (118474-MULTI (XX)), which state - Results from the TEG analyzer should not be the sole basis for a patient diagnosis TEG analyzer results should be considered along with a clinical assessment of the patient's condition and other coagulation laboratory tests.
Quantity in Commerce 3933 kits (US); 2429 kits (OUS)
Distribution Domestic distribution US Nationwide.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JPA and Original Applicant = HAEMOSCOPE CORP.
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