Device product
V8 Immunodisplacement Kit REF 1803
Z-1244-2022
Product summary
- Event
- Event 90060
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 51 kits
- Official record key
device-enforcement:Z-1244-2022
Official wording
Reason: Due to microbial growth causing interference with interpretation.
Code information: Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803
Distribution pattern: U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
Derived failure modes
-
Microbial contamination
microbial growth