Cytocell Aquarius D13S319 Probe Recalled for Package Insert Error
Cytocell Ltd. is recalling Aquarius D13S319 Plus Deletion Probes because the chromomap on the package insert contains an error.
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 by definition is unlikely to cause adverse health consequences, and the issue is a documentation error on the package insert.
Plain-English summary
Cytocell Ltd. is recalling 400 units of the Aquarius D13S319 Plus Deletion Probe, Model LPH068-A. The recall is due to an error in the chromomap provided on the package insert.
The affected products were distributed worldwide, including in the United States and Canada. Specific U.S. states listed include AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI. The affected lot numbers are 058585, 061111, 061354, and 062527.
This is a Class III recall, indicating the product is not likely to cause adverse health consequences. Users should contact the manufacturer for further instructions regarding the package insert error.
The recalled product
- Product
- Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in…
- Manufacturer
- Cytocell Ltd.
- Hazard
- Affected units
- 400
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 (4)
- Lot Numbers: 058585
- 061111
- 061354
- 062527
Distribution
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