Riverain Medical Group RapidScreen RS-Digital, Medical Image Analyzer. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RapidScreen RS-Digital, Medical Image Analyzer.
Brand
Riverain Medical Group
Lot Codes / Batch Numbers
Serial numbers: 58HVH31, F8HVH31, 49HVH31, 87HVH31, 47HVH31, F7HVH31, H7HVH31, 2RCTH31, 1RCTH31, B8HVH31, GQCTH31, G031M31, C031M31, 3131M31, 8031M31, 1131M31, 2FNNS31, BDNNS31, GDNNS31, FDNNS31, JDNNS31, GFNNS31, 2433X31, D333X31, F433X31, 5L3R241, 7L3R241, 148HN41, 648HN41, 348HN41, 848HN41, 838HN41, BR5VQ41, 4R5VQ41, JL0VQ41, JL0VQ41, 3N0VQ41, 2P0VQ41, BPZTQ41, FL0VQ41, 946VQ41, 296VQ41, 9M0VQ41, CL0VQ41, H86VQ41, 1QCWQ41, 1LCWQ41, 5LCWQ41, JNCWQ41, 596VQ41, 4NCWQ41, 9LCWQ41, GM0VQ41, BNCWQ41, 8QCWQ41, DN0VQ41, F26VQ41, B86VQ41, G96VQ41, 996VQ41, JR5VQ41, 2BCKM51, F9CKM51, 79CKM51, H9CKM51, 39CKM51, C9CKM51, 1BCKM51, 59CKM51, 4BCKM51, 20-168, 20-160, and 7S5VQ41.
Products Sold
Serial numbers: 58HVH31, F8HVH31,49HVH31, 87HVH31, 47HVH31, F7HVH31, H7HVH31, 2RCTH31, 1RCTH31, B8HVH31, GQCTH31, G031M31, C031M31, 3131M31, 8031M31, 1131M31, 2FNNS31, BDNNS31,GDNNS31, FDNNS31, JDNNS31, GFNNS31, 2433X31, D333X31, F433X31, 5L3R241, 7L3R241, 148HN41, 648HN41, 348HN41, 848HN41, 838HN41, BR5VQ41, 4R5VQ41, JL0VQ41, JL0VQ41, 3N0VQ41, 2P0VQ41, BPZTQ41, FL0VQ41, 946VQ41, 296VQ41, 9M0VQ41, CL0VQ41, H86VQ41, 1QCWQ41, 1LCWQ41, 5LCWQ41, JNCWQ41, 596VQ41, 4NCWQ41, 9LCWQ41, GM0VQ41, BNCWQ41, 8QCWQ41, DN0VQ41, F26VQ41, B86VQ41, G96VQ41, 996VQ41, JR5VQ41, 2BCKM51, F9CKM51,79CKM51, H9CKM51, 39CKM51, C9CKM51, 1BCKM51, 59CKM51, 4BCKM51, 20-168, 20-160, and 7S5VQ41.
Riverain Medical Group is recalling RapidScreen RS-Digital, 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