FDA Device

Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.

Hazard

A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.

What You Should Do

Remedy

The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.

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Products

Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
Brand
Roche Diagnostics Corp.
UPC
All units with software version 08-02.

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