FDA Device recall Z-0937-2018
Liquid Cardiac Control CQ5053
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Liquid Cardiac Control CQ5053 by Randox Laboratories, citing randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0937-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-08 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | n/a |
Product
Liquid Cardiac Control CQ5053
Reason
Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.
Identifiers
| code_info | Lot 4069CK |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0937-2018%22
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