Response Biomedical Recalls RAMP Cardiac Controls Due to Signal Loss
Response Biomedical Corp. is recalling RAMP Cardiac Controls because CK-MB levels decreased by up to 57% within 11 months, potentially affecting quality control results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves a decrease in signal strength for a quality control product rather than a direct patient safety risk like a high-risk pathogen or structural defect, fitting the criteria for moderate severity.
Plain-English summary
Response Biomedical Corp. is recalling 543 units of RAMP Cardiac Controls (Catalogue Number C2003-2, Lot #070318). The product, originally manufactured by Randox Laboratories Ltd. (Catalogue Number CQ5052, Lot Number 4244CK), is used for the quality control of cardiac marker assays on the RAMP platform.
The recall was initiated after three complaints were received regarding results falling below the target range for CK-MB. In-house monitoring determined that the liquid Cardiac Control experienced a decrease in CK-MB levels of up to 57% signal loss within 11 months, despite a stated shelf-life of 24 months.
The affected units were distributed worldwide, including in the United States (IN, GA, OK, KS, AZ, SC, NE, NC, MI, FL, CA, MN, and AR) and in Canada, Italy, Malaysia, Kuwait, Saudi Arabia, UAE, Ukraine, Russia, Dominican Republic, France, Mexico, Colombia, Singapore, China, Serbia, Romania, and the Philippines. Users should stop using the product and contact Response Biomedical Corp. for instructions.
The recalled product
- 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…
- Manufacturer
- Response Biomedical Corp.
- Hazard
- Affected units
- 543
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Randox Laboratories Ltd. Catalogue Number CQ5052
- Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2
- Lot #070318). UDI Code: (01) 1 0627966 00508 4 (10) 070318 (17)300919
Distribution
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