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U.S. Department of Health and Human Services

Class 3 Device Recall Aquarius CSF1R/RPS14 (5q32q33) Probe Red, Model LPH540A

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  Class 3 Device Recall Aquarius CSF1R/RPS14 (5q32q33) Probe Red, Model LPH540A see related information
Date Initiated by Firm March 15, 2019
Create Date April 19, 2019
Recall Status1 Terminated 3 on October 13, 2020
Recall Number Z-1202-2019
Recall Event ID 82599
Product Classification Reagents, specific, analyte - Product Code MVU
Product Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Code Information Lot numbers: 056996 061156 062616 062808
Recalling Firm/
Manufacturer		 Cytocell Ltd.
Somerville Court, Unit 8
Banbury Business Park
Adderbury Banbury Oxfordshire United Kingdom
Manufacturer Reason
for Recall		 There is an error in the chromomap included in the labeling for the product.
FDA Determined
Cause 2		 Labeling Change Control
Action Urgent Medical Device Recall notification letters dated 3/15/19 were sent to customers.
Quantity in Commerce 19
Distribution The products were distributed to the following US states: IL, TN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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