CoaguChek XS Pro meters (catalog number 05530199160)bar… recallZ-1114-2013 · Roche Diagnostics Operations, Inc. · initiated Mar 6, 2013
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
Consignees of both devices were notified by Urgent Medical Device Correction letters sent via UPS Ground (receipt required) beginning 3/06/2013. The notice contained recommendation not to use EAN-13 barcode system and ensure barcodes used meet quality standards; use operator and patient lists (downloaded from a data manager) in order to check any decoded identification against the respective list. The notice directed forwarding of the notice if the product was further distributed. Customers were asked to complete the attached fax form. Contact the Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 for Accu check questions and 1-800-428-4674 for CoaguChek questions about the information contained in this UMDC.
Recall details
- Recall number
- Z-1114-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 6, 2013
- Posted by the FDA
- Apr 15, 2013
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 4467 both devices
- Product code
- GJS
- FDA submissions
- K093460
- Distribution
- Nationwide Distribution.
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").
Code information (models, lots, serial numbers)
catalog number 05530199160
Other devices under the same FDA submission
1 device cleared under K093460 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CoaguChek XS Pro Kit 5530199160Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 64460).
- Z-1113-2013 · TerminatedACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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