Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 16, 2013
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transm…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Horiba Instruments, Inc dba Horiba Medical recalled ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 - a moderate-severity action.
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 was recalled by Horiba Instruments, Inc dba Horiba Medical in January 16, 2013. Reason: Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data ma…. Check the official notice for the remedy. Verify recall #Z-0645-2013 with the FDA Devices before acting.
The recall
Horiba Instruments, Inc dba Horiba Medical issued this moderate-severity FDA Devices recall-Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data ma….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- January 16, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0645-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0645-2013) was formally reported on January 16, 2013, with the manufacturer initiating the action on September 20, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Horiba Instruments, Inc dba Horiba Medical is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 10 units.
The documented reason for this recall is: Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information Syst… Distribution data in the federal record shows the product reached: Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.. 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
10 units
Related Recalls
6
3 from same agency
Product description
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Reason for recall
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0645-2013 |
| Date reported | January 16, 2013 |
| Date initiated | September 20, 2012 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Firm location | Irvine, CA |
| Affected scope | 10 units |
| Distribution | Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail. |
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-0645-2013) 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? ▼
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2. Recalled by Horiba Instruments, Inc dba Horiba Medical. Units affected: 10 units.
Why was this product recalled? ▼
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 16, 2013. Severity: Moderate. Recall number: Z-0645-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0645-2013) 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 January 16, 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.