—#107580

Product

Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended 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: Expiration dates: 009091 10/10/2010 109636 09/30/2011 013491 10/31/2010 113465 10/31/2011 013492 11/30/2010 113969 10/31/2011 014488 12/31/2010 114261 11/30/2011 015211 02/28/2011 115485 12/31/2011 018855 03/31/2011 116660 01/31/2012 020420 04/30/2011 118211 02/28/2012 021285 05/31/2011

Why it was recalled

The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.

Root cause (FDA determination)

Process design

Action the firm took

Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 9, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard all remaining inventory. In addition, a Response Form was enclosed for customers to complete and return. Contact Beckman's Customer Support Center at (800) 854-3633 for questions regarding this notice.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.

Timeline

Recall initiated: 2011-11-10
Posted by FDA: 2012-03-21
Terminated: 2012-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107580. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.