BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
This recall has been terminated (originally issued September 24, 2018).
- Recall Initiated
- September 24, 2018
- Terminated
- April 10, 2020
- Recall Number
- Z-0313-2019
- Quantity
- 49
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
Distribution
Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. Countries of Spain, Germany, France, Austria, Denmark, Switzerland, Sweden, Italy, Kuwait, Oman, Saudi Arabia, and Turkey.
Lot / Code Info
Serial Numbers: CTI1201-CTI1288
Root Cause
Nonconforming Material/Component
Action Taken
Urgent Medical Device Product Recall notification letters dated 9/24/18 were sent to customers.