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Terminated

ProSpecT Campylobacter Microplate Assay. Catalog #2476096.

FDA Recall Z-1372-04 · Posted 2004-08-17

Recalling FirmRemel, Inc.
Recall StatusTerminated
Product CodeLQP
Date Initiated2002-07-15
Date Terminated2006-12-28
Product Quantity382

Reason for Recall

A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.

Firm Action

Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.

Root Cause

Other

Distribution Pattern

Entire lot was shipped to one customer in Russelsheim, Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982315PROSPECT CAMPYLOBACTER MICROPLATE ASSAYAlexon - Trend, Inc. · 1998-11-18

Official Source

View FDA Recall →

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

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