—#100390

Product

Access Immunoassay Systems Quality Control Kits, Part Number: 37309 The Access Ostase QC is used for monitoring system performance of the Access Ostase assay.

FDA product code: JJX — Single (Specified) Analyte Controls (Assayed And Unassayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K994277
Affected lot / code info: Lot Numbers: 911585, 015211, 018855, 020420, 021285, 021640

Why it was recalled

The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers. Operator injury may occur due to contact with broken glass, exposure to infectious agents, and/or exposure by skin contact to agents that may cause sensitizatio

Root cause (FDA determination)

Package design/selection

Action the firm took

Beckman Coulter sent an PRODUCT CORRECTIVE ACTION (PCA) letter on May 10, 2011 to all affected customers who purchased Access Ostase Calibrators and Access Ostase QC. The letter identified the customers with an explanation of the problem and the potential impact should the problem occur and the action needed to be taken. Customer were instructed to: (1) Inspect all Access Ostase Calibrator and QC vials and packaging for signs of failure prior to use, including: -Cracking, particularly along the bottom of the vial, -Absence of reagent and/or leaking of contents into the box (2) Human source material used in the preparation of Access Ostase Calibrator and QC material has been tested and found non-reactive for Hepatitis B (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV-1 and HIV-2). No known test method can offer complete assurance that infectious agents are absent. Access Ostase Calibrator and QC vials should be handled in accordance with Good Laboratory Practices, and should be handled as if capable of transmitting infectious disease. (3) Skin contact with Access Ostase Calibrator and QC material may cause sensitization. Wear suitable gloves when handling vials. If contact with skin occurs, wash immediately with plenty of soap and water. Customers were told to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide a copy of the letter to them. In addition, customers were requested to complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. For replacement of defective vials: (1) In the United States, please contact Client Services at 1-800-526-3821, option 1. (2) In Canada, please contact Customer Service at 1-800-463-7828. (3) Outside of the United States and Canada, contac

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Nationwide in US and worldwide to: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, New Zealand, Panama, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom

Timeline

Recall initiated: 2011-05-10
Posted by FDA: 2011-06-21
Terminated: 2012-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100390. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.