ABX PENTRA Calcium CP Reagent — Class III medical device recall Z-2280-2013
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2013-10-02. HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect cal
| Recall number | Z-2280-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical, Irvine, CA, United States |
| Recall initiated | 2013-09-06 |
| Classified | 2013-09-26 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2014-08-23 |
| Countries outside the US | CA |
| Serial numbers | 014664503ABX |
| Model numbers | A11A01633 |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.