Recall Z-1001-2020 ยท GKZ Counter, Differential Cell
Clinical Diagnostic Solutions, Inc.
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
| Date | Jan 2, 2020 |
| Status | Terminated |
| Reason | A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle. |
| Root cause | Software design |
| Action | Consignees notified via email and postal delivery with recall letter dated 01/02/2020. The letter identified affected product, stated reason for recall, and provided specific actions to follow. A Recall Acknowledgement Form was requested to be returned by email, postal delivery, or fax. Clinical Diagnostic Solutions Inc. is handling US consignees only. Boule Medical AB is handling OUS consignees. |
| Quantity | 261 |
| Distribution | Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083420 | MEDONIC M SERIES Boule Medical AB, Feb 3, 2009 |