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Terminated

Diamedix Is-CMV IgG Test Kit

FDA Recall Z-1689-2016 · Posted None

Recalling FirmDiamedix Corporation
Recall StatusTerminated
Product CodeLFZ
Date Initiated2015-03-26
Date Terminated2018-11-14
Product Quantity150 kits

Reason for Recall

Product contained an incorrect substrate.

Firm Action

On March 26, 2015 Erba Diagnostics sent a communication to their clients informing them of the recall and sending t hem a replacement sustrate HRP to replaced the wrong one sent on the kit.

Root Cause

Other

Distribution Pattern

AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981163DIAMEDIX IS-CMV IGG TEST SYSTEMDiamedix Corp. · 1998-09-21

Official Source

View FDA Recall →

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

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