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Terminated

LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

FDA Recall Z-0914-05 · Posted 2005-06-21

Recalling FirmEsa Biosciences, Inc.
Recall StatusTerminated
Product CodeDOF
Date Initiated2005-05-19
Date Terminated2005-11-21
Product Quantity14,760 test kits

Reason for Recall

Lead test results may be reported lower than the actual value

Firm Action

ESA is notifying beginning 5/19/05 to Distributors and End Users by letter sent First Class Mail. Additionally Distributors may be notified by phone to ensure receipt of letter. Customers will be asked to return product to ESA for destruction. A fax back form is included with the notification letter. Customers will fax back the number of Test Kits that they require replacement for. ESA will ship replacement kits and include a prepaid return shipping label for the customer to return defective kits to ESA.

Root Cause

Other

Distribution Pattern

United States Foreign: Mexico, Canada, Indonesia, Palestine, Kingdom of Saudi Arabia, Columbia, Switzerland, Romania, West Indies, Italy, Japan, Turkey, United Kingdom, Phillipines, Singapore, Jamaica, Uraguay, South Korea, Peru, Tanzia, South Africa, Quatar, Croatia, Zambia, China, Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971640LEADCARE BLOOD LEAD TESTING SYSTEMEsa, Inc. · 1997-09-09

Official Source

View FDA Recall →

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

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