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.
What this means for you
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 green
- 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
Related recalls
Same manufacturer · Cytocell Ltd.
See all →- HighRET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences
FDA (Devices) · 2023-07-26
- HighFDA Recalls RET Proximal Probe Laboratory Diagnostic Kits for Inverted DNA
FDA (Devices) · 2023-07-26
- ModerateLaboratory Diagnostic Probe Recalled for Incorrect Chromosome Map Labeling
FDA (Devices) · 2022-12-07
- ModerateBCL11B Diagnostic Reagent Recalled for Chromomap Documentation Error
FDA (Devices) · 2022-12-07
- ModerateCytocell Microscope Slides Recall: Incorrect Expiry Date on Label
FDA (Devices) · 2022-03-30
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02