A product recall letter was issued to all architect customers who have received architect creatine kinase, list number 07d63-21, lot number 99632un18.The letter informs the customer of the issue regarding a stability issue that may lead to quality control results shifting low out of range and/or error code 1054 "unable to calculate result, reaction check failure" for quality control and patient samples.The letter instructs the customer to discontinue use of the suspect lots and destroy any remaining inventory.The cause of the stability failure has been traced to a contamination of the bulk material.
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The customer observed error code 1054 unable to calculate result, reaction check failure, and flagged results of <70 u/l for multiple patient samples when using the architect creatine kinase assay (list number 7d63, lot number 99632un18).Multiple sample ids were provided that only generated error code 1054 or <70.The following examples were provided which generated error code 1054 or <70 on one analyzer and a valid result was obtained on a second analyzer.(b)(6) generated 1054 and when retested on second analyzer generated 416 u/l; (b)(6) generated <70 and 1054 and retest on second analyzer generated 79 u/l.No impact to patient management was reported.
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