Roche Diagnostics Corp. Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lot 69535801.
Products Sold
Lot 69535801.
Roche Diagnostics Corp. is recalling Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche due to Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Recommended Action
Per FDA guidance
Consignees were notified via an Urgent Medical Device correction letter dated 6/11/08 informing users of the problem and providing them with work-around instructions. The instructions suggests 1) inserting the cassette rack slowly; 2) using mainly reagent slots A, B, or C; 3) tilting the rack slightly clockwise so the barcode scanner does not read the barcode at an exact 90 degree angle; and 4) confirming the rack is properly seated on the track and displayed on the Cassette Status screen. If the cassette barcode does not register after following the Work-Around instructions, then customers are required to contact Diagnostics Technical Support.
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