—#146785

Product

Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K922823
Affected lot / code info: Serial No. 505143, 504805, 501368, 504231

Why it was recalled

Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An Urgent Medical Device Recall letter dated 5/17/16 was sent to customers to inform them that Beckman Coulter is recalling the Access 2 Immunoassay System, Remanufactured instrument, because it may not have all the updated thermal components installed. The letter informs customers of the impact and actions to be taken. The letter informs the customers that their Service Representative will contact them to schedule an onsite visit to inspect their instrument and update as needed. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center: http://www.beckmancoulter.com, 1-800-854-3633 in the United States and Canada. Customers outside the United States and Canada are instructed to contact their local Beckman Coulter representative.

Recalling firm

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

Distribution

Distribution pattern: US, Morocco, Venezuela

Timeline

Recall initiated: 2016-05-17
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146785. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.