Becton Dickinson Recalls Gonorrhea Test Kits Due to False Positives
Becton Dickinson is recalling 77 BD ProbeTec Neisseria gonorrhoeae Qx Amplified DNA Assay Reagent Packs due to increased levels of false positives.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves increased false positives, which is a diagnostic accuracy issue rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate severity criteria for labeling or performance errors without reported physical harm.
Plain-English summary
Becton Dickinson & Co. is recalling 77 units of the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124. The recall is being conducted because of increased levels of false positives in the assay kits.
The affected product is identified by Lot No. 2237214 and an expiration date of 2013-10-31. The kits were distributed in the states of California, Florida, Georgia, New Jersey, and Texas. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
Healthcare providers and consumers should stop using the affected kits and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson a
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 77
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 No./Exp. Date: 2237214 / 2013-10-31.
Distribution
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