Z-1202-2019 Class III Terminated
FDA device recall Z-1202-2019 was initiated by Cytocell Ltd. on March 15, 2019 and is designated Class III. Reason for recall: There is an error in the chromomap included in the labeling for the product. The recall status is terminated (terminated October 13, 2020). Affected quantity: 19.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- March 15, 2019
- Termination Date
- October 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19
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.
Distribution Pattern
The products were distributed to the following US states: IL, TN.
Code Information
Lot numbers: 056996 061156 062616 062808