Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1114-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").

Product Classification:

Class II

Date Initiated: March 6, 2013

Date Posted: April 24, 2013

Recall Number: Z-1114-2013

Event ID: 64460

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.

Status: Terminated

Product Quantity: 4467 both devices

Code Information:

catalog number 05530199160

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated