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Terminated

Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.

FDA Recall Z-0574-06 · Posted 2006-02-28

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLFW
Date Initiated2006-02-10
Date Terminated2006-06-23
Product Quantity1806 kits

Reason for Recall

May have tobramycin over-recovery at the trough level.

Firm Action

Consignees were notified via phone and faxed recall letter on or about 2/10/06.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912143CEDIA(R) TOBRAMYCIN ASSAYMicrogenics Corp. · 1991-07-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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