Class 2 Device Recall EPO Calibration Verifiers

• Date Initiated by Firm: September 30, 2005
• Date Posted: November 15, 2005
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-0136-06
• Recall Event ID: 33774
• Product Classification: Assay, Erythropoietin - Product Code GGT
• Product: Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512
• Code Information: Kit lots# 63-502081, 63-502081A contain Calibration Verifiers 1, 2, and 3. Lot #30-500952 is specific to Calibration Verifier 2; Lot #30-500953 is specific to Calibration Verifier 3.
• FEI Number: 2050095
• Recalling Firm/ Manufacturer: Nichols Institute Diagnostics; 1311 Calle Batido; San Clemente CA 92673-6316
• For Additional Information Contact: John Chiechi; 949-940-7377
• Manufacturer Reason for Recall: Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2.
• FDA Determined Cause: Other
• Action: Written notification was sent via fax on 9/29/05. If receipt was not confirmed, written version of notification was mailed via next day delivery. NID intends to track the response forms and if after 2 weeks after distribution not all forms have been received, NID will conduct a follow-up phone call and resend if necessary.
• Quantity in Commerce: 215
• Distribution: CA, IN, WA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.