Liquid Cardiac Control, CQ5052
FDA Recall Z-0381-2019 · Posted None
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Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJJY
Date Initiated2018-10-02
Date Terminated2019-05-30
Product Quantity1738
Reason for Recall
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
Firm Action
On October 2, 2018, the firm notified distributors of the recall via Expanded Urgent Medical Device Correction email. Customers were informed that the recall was related to previous recall REC334 on June 8, 2018. The firm has confirmed that Liquid Cardiac Controls CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
Customers were advised to take the following actions:
- Discontinue use of these products for the Quality Control (QC) monitoring of Troponin T assays.
- Discuss the contents of this notice with your Medical Director.
- Update kits with revised IFUs excluding Troponin T values and the attached important notice to prevent further use of the device in the QC of Troponin T assays.
- Complete and return the vigilance response section of this form to [email protected] within five working days.
- Contact your local Randox sales representative for alternative product details.
You may contact the firm at [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed to IN, NY, PR, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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