Recall Z-3113-2017 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fl
| Date | Jun 26, 2017 |
| Status | Terminated |
| Reason | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples. |
| Root cause | Labeling Change Control |
| Action | Beckman Coulter sent an Urgent Medical Device Recall letter dated June 30, 2017, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the information with their laboratory staff. If they forwarded any of the affected product to another laboratory, please provide them a copy of the letter. Customers with questions should contact the Customer Support Center at 800-528-7694. |
| Quantity | 6763 units |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech repu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011342 | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc., Jul 9, 2001 |
| K022161 | MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc., Jul 29, 2002 |
| K030606 | COULTER LH 750 BODY FLUIDS APPLICATION Beckman Coulter, Inc., Apr 21, 2003 |
| K032342 | COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc., Sep 26, 2003 |
| K050057 | COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc., Feb 10, 2005 |
| K052905 | MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc., Nov 18, 2005 |