Liquid Cardiac Control, CQ5053
Reported: November 14, 2018 Initiated: October 2, 2018 #Z-0382-2019
Product Description
Liquid Cardiac Control, CQ5053
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.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 2108
- Distribution
- Distributed to IN, NY, PR, and WV.
- Location
- Crumlin (North)
Frequently Asked Questions
What product was recalled? ▼
Liquid Cardiac Control, CQ5053. Recalled by Randox Laboratories Ltd.. Units affected: 2108.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0382-2019.
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