Roche Diagnostics Corp. Roche Elecsys total PSA, catalog number 11731262322. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche Elecsys total PSA, catalog number 11731262322.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lot 171640.
Products Sold
Lot 171640.
Roche Diagnostics Corp. is recalling Roche Elecsys total PSA, catalog number 11731262322. due to There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
Recommended Action
Per FDA guidance
Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
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