Roche Diagnostics Corp. AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lot E11927, exp. 10/04.
Products Sold
Lot E11927; exp. 10/04.
Roche Diagnostics Corp. is recalling AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190. due to Marketed without PMA or 510(k) approval.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without PMA or 510(k) approval.
Recommended Action
Per FDA guidance
Consignees were notified of the removal by phone on 3/10/04.
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 noticeDistribution
As reported by FDA
FL, VA
Page updated: Jan 10, 2026