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Terminated

Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.

FDA Recall Z-0062-04 · Posted 2003-10-24

Recall StatusTerminated
Product CodeLLH
Date Initiated2003-09-23
Date Terminated2004-03-29
Product Quantity2030 kits

Reason for Recall

The kits were packaged with incorrect dispensing pipettes.

Firm Action

The firm notified their affected consignees by letter on 9/23/2003.

Root Cause

Other

Distribution Pattern

The kits were shipped to consignees located nationwide, and into New Zealand, Haiti, Belgium, Italy, Brazil, Australia, Canada, and Chile.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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