Recall Z-3113-2017
Beckman Coulter Inc. · initiated June 26, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 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, or any other test that aids in diagnosing an abnormality
Codes / lots: Catalog Number(s): LH 750 System - 6605632, A85570, A68807; LH 780 System - 723585, A90728, A68808; LH 500 system - 6605525, 6605526, 6605527, A85566, A85564; All software versions
Reason for recall
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-3113-2017
- Initiated
- June 26, 2017
- Terminated
- September 14, 2023
- Product code
- GKZ – Counter, Differential Cell
- 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 republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe…
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3114-2017 Class II | Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer…Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In… | 06/26/2017Terminated |