Recall Z-1461-2020— Response Biomedical Corp.
Class II · Terminated
Class II FDA medical device recall by Response Biomedical Corp., initiated 2019-03-15, terminated 2022-06-09. It names one FDA 510(k) clearance: K110534. Product: Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.. Reason: The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months..
- Recalling firm
- Response Biomedical Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-15
- Terminated
- 2022-06-09
- Firm location
- Vancouver, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.
Reason for recall
The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.
Data sourced from openFDA. This site is unofficial and independent of the FDA.