Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 9, 2013
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two…
Horiba Instruments, Inc dba Horiba Medical recalled PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemi… — a moderate-severity action.
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemi… was recalled by Horiba Instruments, Inc dba Horiba Medical in January 9, 2013. Reason: Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra…. Check the official notice for the remedy. Verify recall #Z-0633-2013 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 the ABX PENTRA AST CP because during the AST application validation on the Pentra….
- Moderate
- severity level
- 384 units
- affected scope
- Class II
- classification
- January 9, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0633-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0633-2013) was formally reported on January 9, 2013, with the manufacturer initiating the action on October 10, 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 384 units.
The documented reason for this recall is: Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800… Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
384 units
Related Recalls
6
6 from same agency
Product description
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
Reason for recall
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0633-2013 |
| Date reported | January 9, 2013 |
| Date initiated | October 10, 2012 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Firm location | Irvine, CA |
| Affected scope | 384 units |
| Distribution | Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX. |
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-0633-2013) 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? ▼
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.. Recalled by Horiba Instruments, Inc dba Horiba Medical. Units affected: 384 units.
Why was this product recalled? ▼
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 9, 2013. Severity: Moderate. Recall number: Z-0633-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0633-2013) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 9, 2013.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.