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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 2, 2013. Severity: Low. Recall number: Z-2280-2013.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - USA including the country of Canada..

Q: 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.

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 #: Z-2280-2013
Affected scope: 2,658 units ( 1240 US 1418 OUS )
Initiated: September 6, 2013

Compiled from official public sources by the publisher. · Updated September 2026

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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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

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

Structured summary of the FDA Devices recall record
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.

Scale of Impact

2,658 units ( 1240 US 1418 OUS ) units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

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? ▼

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..

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.

Nationwide recalls with similar severity or category timing

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This recall: FDA Devices, reported October 2, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026