Roche Diagnostics Corp. Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units with software version 08-02.
Products Sold
All units with software version 08-02.
Roche Diagnostics Corp. is recalling Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642 due to A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
Recommended Action
Per FDA guidance
The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.
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