Roche IT3800 Hand-Held Barcode Scanner Recalled for Mis-Identification
Roche Molecular Systems is recalling 6,939 IT3800 hand-held barcode scanners because they mis-identified sample barcodes when used with the COBAS AmpliPrep instrument.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (mis-identification of medical samples) where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 6,939 units of the Hand-Held Scanner USB IT3800. These devices are used for sample identification and tracking when paired with various systems, specifically the COBAS AmpliPrep instrument. The recall was initiated because the scanners mis-identified sample barcode IDs.
The affected units were distributed nationwide. The specific material number for the recalled items is IVD: 5401062001. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Users of the IT3800 scanner should stop using the device and contact Roche Molecular Systems, Inc. for further instructions on how to return or replace the affected units. This recall is limited to the specific model and material number listed above.
The recalled product
- Product
- Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
- Manufacturer
- Roche Molecular Systems, Inc.
- Affected units
- 6,939
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)
- Material Number - IVD: 5401062001
Distribution
Distributed nationwide across the United States.
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