Roche Recalls Accu-Chek Inform II Barcode Scanners Due to Decoding Errors
Roche Diagnostics is recalling Accu-Chek Inform II and CoaguChek XS Pro barcode scanners because they may intermittently misread patient identification barcodes.
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 involves a medical device with a risk of patient identification errors, which is a risk-of-harm product where specific injury or illness has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner and the CoaguChek XS Pro System barcode reading meters. These devices are used to quantitatively measure glucose and other parameters. The recall involves 4,467 units of both devices, identified by part numbers 05060311001 and 05060303001.
The recall was initiated after a Roche investigation into complaints revealed that the barcode reading meters have the potential for intermittent erroneous decoding of patient identification. This issue occurs if the barcodes being read fail to meet specific size and/or quality standards. The devices were distributed nationwide.
Consumers and healthcare providers should stop using the affected barcode scanners and contact Roche Diagnostics Operations, Inc. for instructions on how to return or replace the devices.
The recalled product
- Product
- ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 4,467
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)
- part number 05060311001
- 05060303001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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