COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial Numbers(s): All Serial Numbers The COULTE

FDA device recall Z-1979-2011 · posted 2011-04-14 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

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

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

GKZ

Quantity affected

1,211 units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Angola Mexico Australia, Azerbaijan, Bangladesh, Bermuda, Botswana, Bulgaria, China, Cote d'Ivoire, Finland, France, Germany, Ghana, Hong Kon

Date initiated

2011-02-23

Date posted

2011-04-14

Date terminated

2012-07-16

Location

Brea, CA

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