Roche Recalls Leaking cobas PCR Urine and Swab Test Kits
Roche Molecular Systems is recalling 84 batches of cobas PCR Urine, Female Swab, and media kits due to reports of leaking media.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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, but the source text describes a physical defect (leaking media) without reporting any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 84 kit batches of cobas PCR Urine Kits, cobas PCR Female Swab Kits, and cobas PCR media kits. The recall is being conducted because numerous complaints have been filed regarding leaking cobas PCR media 4.3 mL IVD units received from various lots of these products.
The affected products are used to collect and transport urine and gynecological specimens for use with the cobas CT/NG Test. The cobas PCR media serves as a nucleic acid stabilizing transport and storage medium. The recall covers specific lot numbers, including Lot S01487 and earlier for the Female Swab Sample Kit, and Lot S01885 and earlier (except lot number S01884) for the Urine Sample Kit.
These products were distributed nationwide. Consumers and healthcare facilities should stop using the affected kits and contact Roche Molecular Systems for further instructions or a replacement.
The recalled product
- Product
- cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The…
- Manufacturer
- Roche Molecular Systems, Inc.
- Affected units
- 84
Distribution
Distributed nationwide across the United States.
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