Randox Urinalysis Control Level 2 Recalled for Incorrect Leukocyte Range
Randox Laboratories is recalling Randox Urinalysis Control Level 2 kits because the leukocyte range for the Siemens Multistix method was incorrect.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the analyte range.
Plain-English summary
Randox Laboratories Ltd. is recalling Randox Urinalysis Control Level 2 (IVD) kits, Reference UC5034. The product is intended for in vitro diagnostic use in the quality control of urine test strips. The recall involves 1 kit with Lot 1020UC and an expiration date of 28 May 2020.
The recall was initiated because the analyte range for Leukocytes for use with the Siemens Multistix method was incorrect. The range has been corrected to NEGATIVE to 3+.
The product was distributed nationwide in the US, including the states of Indiana and West Virginia. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 1
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 (1)
- Lot: 1020UC Exp. Date: 28 May 2020
Distribution
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