Device product
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Z-1202-2019
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 82599
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19
- Official record key
device-enforcement:Z-1202-2019
Official wording
Reason: There is an error in the chromomap included in the labeling for the product.
Code information: Lot numbers: 056996 061156 062616 062808
Distribution pattern: The products were distributed to the following US states: IL, TN.
Derived failure modes
-
Unknown
There is an error in the chromomap included in the labeling for the product.