S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea

FDA device recall Z-1008-2012 · posted 2012-02-13 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results.

Action taken

Radiometer sent a Medical Device Recall letter dated December 28, 2011 to their customers. The letter provided details on the affected devices, description of the problem and actions to be taken. The firm instructed their customers to immediately examine their stock and return any remaining product to Raiometer America Inc. for disposal. The letter states that Radiometer will replace all bottles of the affected lots, at no charge. Customers were asked to complete the attached Recall Response Fax Form and fax to 800-736-0601. For questions regarding the Recall contact Radiometer America Technical support at 1-800-736-0600 opt. 4.

Root cause

Device Design

Status

Terminated

Product code

CGL

Quantity affected

7 boxes/6/175mL bottles

Distribution

Nationwide Distribution (USA) including the states of: NY, PA and TN.

Date initiated

2011-12-16

Date posted

2012-02-13

Date terminated

2014-01-17

Location

Westlake, OH

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