—#98579

Product

COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial Numbers(s): All Serial Numbers The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K030291
Affected lot / code info: Serial Numbers(s): All Serial Numbers

Why it was recalled

The recall was initiated because Beckman Coulter identified a problem with occasional unexpectedly high results for RBC, HCT, PLT and MPV without instrument generated messages, for the first run of a capped patient sample. Upon repeat analysis the results are correct. Patients could be affected as described below: (1) False high RBC and HCT may result in a delay of treatment, or the delivery of

Root cause (FDA determination)

Pending

Action the firm took

The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTION" letter dated February 23, 2011 with an enclosed customer response form to all customers who have the affected instruments via US Postal Service (in US). The letter described the product, problem and actions to be taken. The customers were instructed not to analyze specimens using the Autoloader. Instead, analyze their samples uncapped (open vial) using the Manual (Stat) Mode. The end of this notice includes a Quick Reference for Running Manual Samples. For more detailed instructions, please refer to your instrument's Instructions for Use (IFU), part number 624026, Section 8.4 Running Manual (Stat) Samples. An electronic version of the IFU can be found in the instrument's On-Line Help screen as well as the Beckman Coulter web site. For inconsistent data during patient's follow-up, please consider unusual/unanticipated high or elevated platelet levels as possible falsely elevated results due to this failure. An appropriate action for the need to look-back at previous results is at the discretion of the Laboratory Director, given the fact that laboratories have a variety of measures that are employed to ensure the validity of the results. Some of these provisions include delta checks, laboratory protocols for validating results and interaction with physicians. Additionally, the customers were also requested to complete and return the enclosed PRODUCT CORRECTION RESPONSE FORM within ten (10) days via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015, or email to: Regulatory.notifications@beckmancoulter.com. For any questions concerning this notice, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Angola Mexico Australia, Azerbaijan, Bangladesh, Bermuda, Botswana, Bulgaria, China, Cote d'Ivoire, Finland, France, Germany, Ghana, Hong Kong, India, Italy, Mexico, Netherlands, New Zealand, Nigeria, Palestinian, Puerto Rico, Romania, Russian Federation,Saudi Arabia, Slovenia, South Africa, Spain, Switzerland,Taiwan, Tanzania, and Turkey.

Timeline

Recall initiated: 2011-02-23
Posted by FDA: 2011-04-14
Terminated: 2012-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98579. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.