CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling CoaguChek XS Pro meters (catalog number 05530199160) and Accu-Chek Inform II barcode reading meters. The meters were found to have the potential to intermittently decode patient identification information incorrectly when barcodes fail to meet certain size and quality standards. Errors have been confirmed when EAN 13 barcodes are used for patient or operator identification, though these barcodes should not be used for this purpose.
The recall affects 4,467 devices that were distributed nationwide. The source does not specify what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.
Reason for recall: Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification. Distribution: Nationwide Distribution. Quantity: 4467 both devices Lot/code info: catalog number 05530199160
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.