COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology anal

FDA device recall Z-0113-2014 · posted 2013-11-01 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line.

Action taken

Beckman Coulter sent a Urgent Product Correction letter dated September 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. . The customer notification letter dated September 12, 2013, titled "URGENT PRODUCT CORRECTION", provided product description with codes, the issue (reason for recall), impact, action, resolution, and contact information. Customers were instructed to: If you experience a "Backwash Tank Not Full" error message, review manual mode sample results since the last acceptable QC run. System safeguards that assist with detection of erroneous results include Startup, QC, system messages and flagging (e.g., R), delta checks, flagging from limit sets (H, L, a, c), definitive messages and decision rules that would trigger further review. Avoid physical contact with a possible leak by continuing to use personal protective equipment as recommended in the Instructions for Use and by national regulations. If you have any questions concerning this notification, please contact our Customer Support Center: Via our website, http://www.beckmancoulter.com/customersupport/support Via phone, call 800-526-7694 in the United States and Canada. Outside US and Canada, contact your local Beckman Coulter Representative We apologize for the inconvenience this issue has caused your laboratory.

Root cause

Component change control

Status

Terminated

Product code

GKZ

Quantity affected

1,697 units

Distribution

Worldwide Distribution - Nationwide Distribution and the country of Canada..

Date initiated

2013-09-24

Date posted

2013-11-01

Date terminated

2014-10-09

Location

Brea, CA

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