Roche Recalls CoaguChek XS Pro Meters Due to Barcode Reading Errors
Roche is recalling CoaguChek XS Pro meters and Accu-Chek Inform II barcode scanners because they may incorrectly decode 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential patient identification errors.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling CoaguChek XS Pro meters (catalog number 05530199160) and Accu-Chek Inform II barcode scanners. The recall involves 4,467 devices distributed nationwide.
The recall was initiated after Roche investigated complaints and found that the devices had the potential for intermittent erroneous decoding of patient identification. This issue occurs if the barcodes being read fail to meet specific size or quality standards. The errors have been confirmed with EAN 13 barcodes, which should not be used for patient or operator identification.
The devices are used to quantitatively determine prothrombin time (PT). Consumers and healthcare providers should stop using the affected devices and contact Roche Diagnostics Operations, Inc. for instructions on how to proceed.
The recalled product
- Product
- CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
- 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 (1)
- catalog number 05530199160
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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