Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported October 2, 2013
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calci
HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Horiba Instruments, Inc dba Horiba Medical recalled ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in ma… - a low-severity action.
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in ma… was recalled by Horiba Instruments, Inc dba Horiba Medical in October 2, 2013. Reason: HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect c…. Check the official notice for the remedy. Verify recall #Z-2280-2013 with the FDA Devices before acting.
The recall
Horiba Instruments, Inc dba Horiba Medical issued this low-severity FDA Devices recall-HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect c….
- Low
- severity level
- 3K units
- affected scope
- Class III
- classification
- October 2, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2280-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2280-2013) was formally reported on October 2, 2013, with the manufacturer initiating the action on September 6, 2013. It is classified under Low severity (Class III), 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 2,658 units ( 1240 US 1418 OUS ).
The documented reason for this recall is: HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including the country of Canada.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,658 units ( 1240 US 1418 OUS )
Related Recalls
6
3 from same agency
Product description
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.
Reason for recall
HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2280-2013 |
| Date reported | October 2, 2013 |
| Date initiated | September 6, 2013 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Firm location | Irvine, CA |
| Affected scope | 2,658 units ( 1240 US 1418 OUS ) |
| Distribution | Worldwide Distribution - USA including the country of Canada. |
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-2280-2013) 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 Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.. Recalled by Horiba Instruments, Inc dba Horiba Medical. Units affected: 2,658 units ( 1240 US 1418 OUS ).
Why was this product recalled? ▼
HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2013. Severity: Low. Recall number: Z-2280-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2280-2013) 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 October 2, 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.