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Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS… recallZ-0012-2009 · Roche Diagnostics Corp. · initiated Jun 11, 2008

Terminated All recalls posted in October 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling Change Control

What the company is doing

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.

Recall details

Recall number
Z-0012-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 11, 2008
Posted by the FDA
Oct 9, 2008
Recalling firm
Roche Diagnostics Corp.
Quantity
2
Product code
CGX
FDA submissions
K951595
Distribution
Nationwide Distribution

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.

Code information (models, lots, serial numbers)

Lot 60115501.

Other devices under the same FDA submission

11 devices cleared under K951595 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 48638).

Sources and updates

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