Class 3 Device Recall IMx Total BhCG Reagent

• Date Initiated by Firm: March 24, 2005
• Date Posted: June 16, 2005
• Recall Status: Terminated on September 29, 2005
• Recall Number: Z-0894-05
• Recall Event ID: 31592
• 510(K)Number: K912535
• Product Classification: Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
• Product: IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent
• Code Information: 25459Q100
• Recalling Firm/ Manufacturer: Abbott Health Products, Inc.; Hwy 2 Km 58.0; Barceloneta PR 00617
• For Additional Information Contact: Vana L. Smith, PhD; 877-422-2688
• Manufacturer Reason for Recall: Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
• FDA Determined Cause: Other
• Action: Abbot Health Products, Inc informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 1-800-777-0051. (US only) Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
• Quantity in Commerce: 793 kits
• Distribution: US Goverment, Domestic and International distribution.
• 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.

• 510(K) Database: 510(K)s with Product Code = JHI