Recall Z-2280-2013 ยท CIC Cresolphthalein Complexone, Calcium
Horiba Instruments, Inc dba Horiba Medical
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 bicarbonat
| Date | Sep 26, 2013 (initiated Sep 6, 2013) |
| Status | Terminated |
| 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. |
| 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 pat |
| Quantity | 2,658 units ( 1240 US 1418 OUS ) |
| Distribution | Worldwide Distribution - USA including the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H Horiba Abx, Apr 26, 2007 |