Recall Z-3114-2017 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality
| 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 | 3326 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
| K010765 | COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 Beckman Coulter, Inc., Apr 13, 2001 |