Recall Z-1202-2019 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
| Date | Mar 15, 2019 |
| Status | Terminated |
| Reason | There is an error in the chromomap included in the labeling for the product. |
| Root cause | Labeling Change Control |
| Action | Urgent Medical Device Recall notification letters dated 3/15/19 were sent to customers. |
| Quantity | 19 |
| Distribution | The products were distributed to the following US states: IL, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.