FDA Device Recall Z-0012-2009: Roche Diagnostics Corp.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-2009.

Recall Res Number

Z-0012-2009

Recalling Firm / Manufacturer

Roche Diagnostics Corp.

FEI Number

1823260

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-06-11

Date Posted

2008-10-09

Date Terminated

2009-09-22

Product Code

CGX

Event Number

48638

Product Quantity

Product Description Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.

Reason for Recall Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

Action Details 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.

Distribution Pattern Nationwide Distribution

Code Information / Serial Numbers Lot 60115501.

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Medical Device Recall: Z-0012-2009

Recall Parameters & Description

Related Establishments / Registrations

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