It is unknown if the samples that were tested were hama or rf positive, therefore this incident is conservatively being reported as related to rcr 1415939-07/30/22-002-r.The investigation to-date from fisher diagnostics identified that the manufacturing process order instructions were not clear to manufacturing personnel.Appropriate corrective action(s) will be deployed for any additional contributions to causes subsequently identified in the ongoing investigation.Abbott is responsible for execution of this remedial action and a product recall letter was sent to all customers in receipt of the impacted lot of architect stat troponin-i reagent, ln 2l41-27, lot 38718un22 informing them of the following actions: immediately discontinue use of architect stat troponin-i, list number 2k41-27 lot number 63718un22 and destroy all inventory of lot 63718un22 according to their laboratory procedures.Contact customer support to order replacement material.Review the product recall letter with their medical director or laboratory management and follow their laboratory protocol regarding the need for review of previously reported patient results using lot number 63718un22.(b)(6).All available patient information was included.No additional information was provided.
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Hold cm 10.4 the customer observed falsely depressed architect stat troponin-i results generated on an architect i1000sr analyzer for multiple patients.The customer¿s normal patient values = 0.03.The customer stated they ran 144 troponin tests and had 27 critical values.The customer performed a lot to lot comparison using lot 35628un22 for 24 sample ids of samples run on (b)(6) 2022.The customer noted retesting for (b)(6) was done outside the allowable add on time for retesting and is not considered valid for correlation.The results are as follows: (b)(6) initial result = 0.065 ng/ml, repeat result = 0.143 ng/ml; repeat on other lot = 0.01 ng/ml.(b)(6) initial result = 0.012 ng/ml; repeat on other lot = 0.015 ng/ml.(b)(6) initial result = 0.039 ng/ml, repeat results = 0.047 ng/ml, 0.057 ng/ml, 0.054 ng/ml; repeat on other lot = 0.034 ng/ml.(b)(6) initial result = 0.037 ng/ml; repeat on other lot = 0.04 ng/ml.(b)(6) initial result = 0.038 ng/ml, repeat result = 0.048 ng/ml; repeat on other lot = 0.656 ng/ml.(b)(6) initial result = 0.023 ng/ml; repeat on other lot = 0.02 ng/ml (mustard serum) and 0.004 ng/ml (na heparin plasma).(b)(6) initial result = 0.109 ng/ml, repeat result = 0.108 ng/ml; repeat on other lot = 1.768 ng/ml.(b)(6) initial result = 0.187 ng/ml, repeat result = 0.183 ng/ml; repeat on other lot = 0.22 ng/ml.(b)(6) initial result = 0.179 ng/ml, repeat result = 0.196 ng/ml; repeat on other lot = 0.165 ng/ml.(b)(6) initial result = 0.028 ng/ml; repeat on other lot = 3.742 ng/ml (outside allowable add on time).(b)(6) initial result = 0.026 ng/ml; repeat on other lot = 0.001 ng/ml.(b)(6) initial result = 0.058 ng/ml, repeat result = 0.066 ng/ml; repeat result on other lot = 0.06 ng/ml.(b)(6) initial result = 0.020 ng/ml; repeat on other lot = 0.003 ng/ml.(b)(6) initial result = 0.098 ng/ml; repeat on other lot = 1.065 ng/ml.(b)(6) initial result = 0.099 ng/ml, repeat result = 0.094 ng/ml; repeat on other lot = 0.06 ng/ml.(b)(6) initial result = 0.034 ng/ml, repeat results = 0.027 ng/ml, 0.031 ng/ml, 0.032 ng/ml; repeat on other lot = 0.017 ng/ml.(b)(6) initial result = 0.018 ng/ml; repeat on other lot = 0.00 ng/ml.(b)(6) initial result = 0.108 ng/ml, repeat result = 0.110 ng/ml; repeat on other lot = 0.12 ng/ml.(b)(6) initial result = 0.122 ng/ml, repeat result = 0.109 ng/ml; repeat on other lot = 5.87 ng/ml.(b)(6) initial result = 0.035 ng/ml, repeat result = 0.109 ng/ml; repeat on other lot = 0.025 ng/ml.(b)(6) initial result = 0.001 ng/ml; repeat on other lot = 0 ng/ml.(b)(6) initial result = 0.041 ng/ml, repeat result = 0.034 ng/ml; repeat on other lot = 0.06 ng/ml.(b)(6) initial result = 0.078 ng/ml, repeat result = 0.098 ng/ml; repeat on other lot = 0.08 ng/ml.(b)(6) initial result = 0.065 ng/ml, repeat result = 0.047 ng/ml; repeat on other lot = 0.4 ng/ml.The following sids were identified by the customer as having critical results: (b)(6) initial result = 0.045 ng/ml, repeat result = 0.043 ng/ml.(b)(6) initial result = 0.042 ng/ml, repeat results = 0.045 ng/ml, 0.041 ng/ml, 0.041 ng/ml.(b)(6) initial result = 0.146 ng/ml, no repeat results provided.(b)(6) initial result = 0.081 ng/ml, no repeat results provided.(b)(6) initial result = 0.053 ng/ml, repeat result = 0.065 ng/ml.(b)(6) initial result = 0.127 ng/ml, repeat result = 0.123 ng/ml.(b)(6) initial result = 0.121 ng/ml, repeat result = 0.141 ng/ml.(b)(6) initial result = 0.035 ng/ml, repeat result = 0.051 ng/ml.(b)(6) initial result = 0.034 ng/ml, repeat results = 0.041 ng/ml, 0.028 ng/ml, 0.029 ng/ml.(b)(6) initial result = 0.090 ng/ml, repeat result = 0.072 ng/ml.(b)(6) initial result = 5.033 ng/ml, repeat result = 5.170 ng/ml.(b)(6) initial result = 0.057 ng/ml, repeat result = 0.043 ng/ml.Additional patient results provided: (b)(6) initial result = 0.007 ng/ml, repeat result = 0.008 ng/ml.(b)(6) initial result = 0.028 ng/ml, repeat result = 0.024 ng/ml.(b)(6) initial result = 0.004 ng/ml, repeat result = 0.000 ng/ml.(b)(6) initial result = 0.006 ng/ml, repeat result = 0.006 ng/ml.It is unknown whether the patients are hama or rf positive.No impact to patient management was reported.
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