Z-1751-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- September 4, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1610 units
Product Description
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.
Reason for Recall
Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
Distribution Pattern
Distributed throughout the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY.
Code Information
Catalog Number 475006 ; UDI: 15099590222031; Lot Numbers: M904147 and older including M810039, M901087 and M904147) and 4 lots OP2 (M805122, M810039, and M901087. .