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U.S. Department of Health and Human Services

Class 2 Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit

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  Class 2 Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit see related information
Date Initiated by Firm March 04, 2011
Date Posted July 06, 2011
Recall Status1 Terminated 3 on September 25, 2012
Recall Number Z-2742-2011
Recall Event ID 58847
510(K)Number K002177  
Product Classification Hematology Multipurpose System for In Vitro Coagulation Studies - Product Code JPA
Product TEG Hemostasis System Level II Control:
Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series

Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System
Code Information part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011
Recalling Firm/
Manufacturer		 Haemoscope Division of Haemonetics Corp
6231 W Howard St
Niles IL 60714-3403
For Additional Information Contact Ms. Susan Finneran
800-438-2834
Manufacturer Reason
for Recall		 Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).
FDA Determined
Cause 2		 Other
Action Haemoscope, a Division of Haemonetics Corp, sent a letter dated March 2, 2011 to all of the affected customers. The letters informed the customers that Haemoscope had received a higher than normal inquiry rate for the Level II Quality Control Kits, part 07-008, lots HMO196 and HMO 197. The accounts were requested to return their stocks of those two lots for further testing and evaluation and to complete the enclosed acknowledgement form, confirming receipt of the letter and the number of kit boxes being returned, and fax it back to Haemoscope at 847-588-0455. The returned kits will be replaced at no charge. For additional information please contact Haemoscope at 847-588-0453, ext-217 .
Quantity in Commerce 568 kits
Distribution Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
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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