Recall Z-1202-2019— Cytocell Ltd.
Class III · Terminated
Class III FDA medical device recall by Cytocell Ltd., initiated 2019-03-15, terminated 2020-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.. Reason: There is an error in the chromomap included in the labeling for the product..
- Recalling firm
- Cytocell Ltd.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-03-15
- Terminated
- 2020-10-13
- Firm location
- Adderbury Banbury Oxfordshire, N/A, United Kingdom
Product description
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Reason for recall
There is an error in the chromomap included in the labeling for the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.