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.
Recall
- Recall Number
- Z-0313-2019
- Event Number
- 81145
- Firm
- Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems
- FEI Number
- 1119779
- Product Code
- PQA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 24, 2018
- Terminated
- April 10, 2020
- Address
- Sparks, MD, 21152-9212
Description
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.
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.
Urgent Medical Device Product Recall notification letters dated 9/24/18 were sent to customers.
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.
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