—#102319

Product

ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

FDA product code: JKD — Radioimmunoassay, C-Peptides Of Proinsulin
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: list 3L53-25, lot numbers 03610K000 exp. 10/26/2011; 01711A000 exp. 12/12/2011; 00110L000 exp. 10/29/2011; 01411B000 exp. 01/12/2012; 00611E000 exp. 04/16/2012;

Why it was recalled

C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Abbott Laboratories sent a "PRODUCT RECALL" letter dated July 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the lots and destroy any remaining inventory of the lots according to laboratory procedures. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Trinidad & Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.

Timeline

Recall initiated: 2011-07-11
Terminated: 2012-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102319. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.