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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00047-1
Product Name/Description Alkaline Phosphatase (ALPAMP and ALPDEA), An in vitro diagnostic medical device (IVD)

Test code: ALPAMP
Catalogue number: 03035814
Siemens Material Number: 10309049
Lot numbers: 255406, 260121

Test code: ALPDEA
Catalogue number: 03036535
Siemens Material Number: 10341131
Lot number: 255465

ARTG 176331
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 18/01/2013
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue The affected lots demonstrate an increased incidence of absorbance flags, (u, U) and //// errors. Absorbance flags u and U indicate abnormal high absorbance exceeding either the blank or sample limit. Absorbance flag //// indicates a calculation error and no result is generated by the system.
Recall Action Recall
Recall Action Instructions Siemens Healthcare is advising customers to discontinue use and discard any affected lots. Replacement kits will be provided at free of charge. The increased rate of absorbance flags has not been associated with inaccurate results.
Contact Information 1800 310 300 - Siemens Technical Support Centre