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U.S. Department of Health and Human Services

Class 3 Device Recall RapidScreen RS2000D.

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  Class 3 Device Recall RapidScreen RS2000D. see related information
Date Initiated by Firm May 04, 2006
Date Posted June 27, 2006
Recall Status1 Terminated 3 on February 20, 2013
Recall Number Z-1173-06
Recall Event ID 35456
PMA Number P000041/S1 
Product Classification Medical Image Analyzer - Product Code MYN
Product RapidScreen RS-2000D, Medical Image Analyzer.
Code Information Serial numbers: 39CKM51, 1BCKM51, 25-1034, 4BCKM51, F9CDM51, 25-1011, 25-1012, 25-1013, 25-1015, 25-1017, 25-1021, 25-1025, 25-1028, 25-1029, 25-1023, 25-1024, 25-1027, 25-1033, 25-1030, 25-1031, 25-1035, 25-1036, 25-1032, 25-1037, 25-1038, 25-1039, 25-1041, 25-1042.
Recalling Firm/
Manufacturer		 Riverain Medical Group
3020 S Tech Blvd
Miamisburg OH 45342-4860
For Additional Information Contact Ms. Jennifer Steinke
800-990-3387 Ext. 5446
Manufacturer Reason
for Recall		 The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.
FDA Determined
Cause 2		 Other
Action The recalling firm sent a letter dated 5/4/06 to medical facilities, sent a letter dated 5/5/06 to distributors, and sent a letter dated 5/10/06 to GE Healthcare, Waukesha, WI.
Quantity in Commerce 29 devices
Distribution Nationwide. The product was distributed to consignees located in IL, CA, MO, CO, WA, MT, ID, OR, NC, TX, TN, FL, UT, MN, OK, WI, OH, AZ, IA, and PA.
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.
PMA Database PMAs with Product Code = MYN and Original Applicant = RIVERAIN MEDICAL GROUP
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