Date Initiated by Firm | July 22, 2015 |
Date Posted | August 28, 2015 |
Recall Status1 |
Terminated 3 on December 18, 2015 |
Recall Number | Z-2480-2015 |
Recall Event ID |
71835 |
510(K)Number | K011342 K061616 |
Product Classification |
Diluent, blood cell - Product Code GIF
|
Product | COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets. |
Code Information |
Lot Numbers: 510376F-510657F, M405229-M503553. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
|
For Additional Information Contact | Rula Melconian 714-961-4295 |
Manufacturer Reason for Recall | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | An Urgent Medical Device Recall letter dated 7/22/15 was sent to the affected
customers to inform them of the issue and actions to take. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Beckman Coulter's Customer Support Center, http://www.beckmancoulter.com/customersupport/support, (800) 526-7694 in US and Canada. Customers outside of the US and Canada, are instructed to contact their local Beckman Coulter Representative. |
Quantity in Commerce | 409,042 units (339,545 units in US) |
Distribution | Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GIF
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