FDA Device recall Z-2280-2013
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contract…
- FDA Device
- Class III
- terminated
- Published 2013-10-02
On 2013-10-02 the FDA classified a Class III recall of ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contract… by Horiba Instruments, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2280-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-09-06 |
| Published | 2013-10-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Horiba Instruments |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Lot/Serial #(s): 014664503 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2280-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.