Cytocell Aquarius Probe Red Recalled Due to Labeling Error
Cytocell recalls Aquarius CSF1R/RPS14 Probe Red reagent (model LPH540-A) with lot numbers 056996, 061156, 062616, 062808 due to a labeling error in the chromomap.
Lower-risk recall
There is an error in the chromomap included in the labeling for the product.
Contact the company
What happened, in plain English
Cytocell is recalling a specific reagent used in laboratory testing because the labeling contains an error in the chromomap. This error could lead to incorrect test results if the reagent is used without proper understanding of the labeling. Read more at govinfonow.com/recall/68686-cytocell-aquarius-probe-red-recalled-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/68686-cytocell-aquarius-probe-red-recalled-due-to-labeling-error · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1202-2019
Cite this page
“Cytocell Aquarius Probe Red Recalled Due to Labeling Error.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68686-cytocell-aquarius-probe-red-recalled-due-to-labeling-error. Based on FDA recall #Z-1202-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1202-2019%22&limit=1).
Why it’s dangerous
The labeling error in the chromomap could cause laboratory users to misinterpret the product's specifications, potentially leading to inaccurate test results. This is a technical error that does not pose a physical safety risk but affects the accuracy of the reagent's use.
Who’s affected
Laboratory users who purchased the Aquarius CSF1R/RPS14 Probe Red reagent (model LPH540-A) with lot numbers 056996, 061156, 062616, or 062808 are affected. Researchers and technicians working with this reagent are most at risk of incorrect test results.
How to tell if you have this one
Check the lot number on the reagent's packaging. The affected model is LPH540-A with lot numbers 056996, 061156, 062616, or 062808. This reagent is used in laboratory settings for specific analyte testing.
- Brand
Cytoc:ell- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot numbers 056996, 061156, 062616, or 062808 on the reagent packaging.
Where it went and when
Where it was distributed
Distributed in Illinois and Tennessee.
FDA distribution: “The products were distributed to the following US states: IL, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Tennessee.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1202-2019 (March 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1202-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.