Z-2280-2013Class III

ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions...

Name: Z-2280-2013 ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2013-09-06
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2013-09-06 / Terminated

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen... on 2013-09-06. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2280-2013
Classification: Class III
Status: Terminated
Initiated: 2013-09-06
Posted: 2013-09-26
Terminated: 2014-08-23
Recalling firm: Horiba Instruments Incorporated
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.
Product code: CIC Cresolphthalein Complexone, Calcium
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.
FDA root cause: Under Investigation by firm
Action: Horiba Medical sent an Urgent Safety Notice dated September 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer notification letter dated September 6, 2013 will be sent to all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent (Reference #: A11A01633) Lot#: 014664503. The recall letter informs the customers that the initial functional tests indicate that there is no interference identified with regards to the patient results. However, with time, there may be an increase in the quantity of precipitates and this could potentially interfere with the performance of this reagent. Customers are informed of the actions to be taken and to complete the customer response form within 10 days. Further questions please call (949) 453-0500 Ext. 208
Quantity in commerce: 2,658 units ( 1240 US 1418 OUS )
Distribution: Worldwide Distribution - USA including the country of Canada.
Product codes and lots: Lot/Serial #(s): 014664503

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2280-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2280-2013	Class III	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-26

Product code CIC

K070249Class IIAbx Pentra 400, Calcium Cp, Creatinine Cp, Phosphorus Cp, Amylase Cp, Urine Control L/hHoriba Abx / cleared 2007-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)