Riverain Medical Group RapidScreen RS-2000D, Medical Image Analyzer. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RapidScreen RS-2000D, Medical Image Analyzer.
Brand
Riverain Medical Group
Lot Codes / Batch Numbers
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.
Products Sold
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.
Riverain Medical Group is recalling RapidScreen RS-2000D, Medical Image Analyzer. due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026