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U.S. Department of Health and Human Services

Class 2 Device Recall TEG Manager, Accessory to Thrombelastograph Coagulation Analyzer TEG5000 Series

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  Class 2 Device Recall TEG Manager, Accessory to Thrombelastograph Coagulation Analyzer TEG5000 Series see related information
Date Initiated by Firm February 19, 2020
Create Date March 31, 2020
Recall Status1 Terminated 3 on June 21, 2021
Recall Number Z-1617-2020
Recall Event ID 85120
510(K)Number K002177  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1.
Intended: For in vitro coagulation studies
Code Information TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0, and 4.1.1.
Recalling Firm/
Manufacturer		 Haemonetics Corporation
125 Summer St
Boston MA 02110-1616
For Additional Information Contact
781-848-7100
Manufacturer Reason
for Recall		 Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.
FDA Determined
Cause 2		 Software design
Action Haemonetics sent US customers using a TEG 5000 device and TEG Manager software a customer letter via email on February 19, 2020. This customer letter notified end users that Haemonetics is conducting a voluntary correction of all TEG Manager software used in conjunction with the TEG 5000 device. Letter states reason for recall, health risk and action to take: Haemonetics is developing a patch to correct the issue with the TEG Manager software. The patch is expected to be available in March of 2020. Haemonetics will contact customers when the TEG Manager software patch is available for download and we will follow up with each user to ensure that the patch has been received and implemented. In the meantime, customers using TEG Manager with the TEG 5000 device should continue to follow the instructions in the TEG 5000 user manual, which state that, Before making any decisions, the attendant physician must consider all clinical information about the patients condition, the procedure, and previous therapy. Users should rely on the actual value of each test result which is correctly displayed on the TEG 5000 and TEG Manager and should not make clinical decisions based solely on the out of range alerts displayed by TEG Manager software. Recipients of this notice should complete the attached acknowledgement form in its entirety.
Quantity in Commerce 88 units
Distribution US Nationwide distribution.
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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