Recall Z-1001-2020
Clinical Diagnostic Solutions, Inc. · initiated January 2, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Codes / lots: Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-1001-2020
- Initiated
- January 2, 2020
- Terminated
- November 3, 2022
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 261
- Distribution
- Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.
- Recalling firm
- Clinical Diagnostic Solutions, Inc., Plantation, FL