Lower riskMedical device recall · FDA · Published February 13, 2018
Stanbio RaPET RF Latex Reagent Causes Weak Positive Test Results
Stanbio recalls RaPET RF Latex Reagent used in rheumatoid arthritis tests due to weakly positive results in patient serum samples. Affected kits include RaPET RF (1155-100) and others with specific expiry dates.
“Stanbio RaPET RF Latex Reagent Causes Weak Positive Test Results.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71971-stanbio-rapet-rf-latex-reagent-causes-weak-positive-test-results. Based on FDA recall #Z-1070-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1070-2018%22&limit=1).
The FDA announced on Feb. 13, 2018, that Stanbio Laboratory, LP voluntarily recalled RaPET RF Latex Reagent kits due to a hazard where all patient serum samples yield a weakly positive test result. The recall affects approximately 686 units distributed in the United States, Canada, Korea, Mexico, and Trinidad.
Kit Model: RF Latex (1155L-100B), Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31
Lot Code: 21675
The hazard
According to the FDA, the recalled RaPET RF Latex Reagent causes all patient serum samples to yield a weakly positive test result. The product is intended for the qualitative and semiquantitative detection of rheumatoid factor in human serum as an aid in the diagnosis of rheumatoid arthritis.
Context
GovInfoNow's records show Stanbio Laboratory, LP has had four other recalls on record since Feb. 8, 2018. On Oct. 2, 2023, the company recalled STAT-Site M BHB Test Strips due to false negative risk from stability deterioration. On March 16, 2022, Stanbio recalled Creamatocrit Plus because it was marketed as an IVD without a 510(k), risking erroneous breast milk results. On July 12, 2021, the firm recalled Beta-Hydroxybutyrate Reagent A due to stability issues affecting test results.
How to tell if you have this one
Check if your rheumatoid arthritis test kit includes the RaPET RF reagent with lot number 21675. The kits are labeled with specific model numbers and expiry dates.
Brand
Stanbio
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Lot Number
Look for the lot number 21675 on the reagent packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1070-2018 (February 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1070-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 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.