Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of iron in serum and plasma.
FDA Recall Z-0007-2009 · Posted 2008-10-09
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJIY
Date Initiated2008-06-11
Date Terminated2009-09-22
Product Quantity523
Reason for Recall
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Firm Action
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.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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