Device product
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Z-2434-2019
Product summary
- Event
- Event 81383
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 kits
- Official record key
device-enforcement:Z-2434-2019
Official wording
Reason: Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Code information: Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360
Distribution pattern: Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
Derived failure modes
-
Unknown
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.