Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 24, 2013
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
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 id…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Diagnostics Operations, Inc. recalled CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the Co… - a moderate-severity action.
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the Co… was recalled by Roche Diagnostics Operations, Inc. in April 24, 2013. Reason: Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading met…. Check the official notice for the remedy. Verify recall #Z-1114-2013 with the FDA Devices before acting.
The recall
Roche Diagnostics Operations, Inc. issued this moderate-severity FDA Devices recall-Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading met….
- Moderate
- severity level
- Class II
- classification
- April 24, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1114-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1114-2013) was formally reported on April 24, 2013, with the manufacturer initiating the action on March 6, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diagnostics Operations, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 4467 both devices.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4467 both devices
Related Recalls
6
3 from same agency
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").
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1114-2013 |
| Date reported | April 24, 2013 |
| Date initiated | March 6, 2013 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 4467 both devices |
| Distribution | Nationwide Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1114-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 4467 both devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2013. Severity: Moderate. Recall number: Z-1114-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1114-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 24, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.