Roche Recalls cobas 4800 HPV Test Kits Due to Formulation Error
Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for cancer screening where a formulation error could lead to inaccurate diagnostic results. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not classified as FDA Class I.
Plain-English summary
Roche Molecular Systems, Inc. is recalling specific lots of the cobas 4800 HPV AMP/DET kits (US-IVD and CE-IVD) in 240 and 960 test configurations. The recall was initiated after an internal investigation identified a formulation error that occurred during the manufacture of the cobas 4800 HPV Master Mix reagent. The error involved an incorrect tare weight used for the carboy during the final manufacturing steps.
The affected products are distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and South America. The specific lots affected include US-IVD lots R13814 and R15785, and CE-IVD lots R15771 and R15304. The cobas 4800 HPV Test is a qualitative in vitro test used to detect Human Papillomavirus in patient specimens to screen for high-risk HPV types.
Healthcare providers and laboratories should stop using the affected kits and contact Roche for instructions on how to return the product. Patients who have already had testing performed with these specific kits should consult their healthcare provider to discuss the potential impact on their results and management plan.
The recalled product
- Product
- KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of…
- Manufacturer
- Roche Molecular Systems, Inc.
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 (2)
- US-IVD: Material number 05232880190 Lot Number R13814
- R15304
Distribution
Distributed nationwide across the United States.
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