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

FDA device recall Z-2280-2013 · posted 2013-09-26 · Terminated

Recall details

Recalling firm

Horiba Instruments, Inc dba Horiba Medical

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Terminated

Product code

CIC

Quantity affected

2,658 units ( 1240 US 1418 OUS )

Distribution

Worldwide Distribution - USA including the country of Canada.

Date initiated

2013-09-06

Date posted

2013-09-26

Date terminated

2014-08-23

Location

Irvine, CA

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