Caller alleged false negative hcg results on two lots.Results as follows: one patient sample gave a false negative hcg result on two lots.The customer did not believe the test result, so they had a quantitative serum test done that came out to approx 35miu/ml.The same urine sample was ran on their chemistry analyzer and received 37miu/ml, though the customer states urine is not approved for use on their chemistry analyzer.They then tested a third lot of the same alere hcg test and it showed a positive result.The customer also prepared hcg dilutions for a sample approx 25miu and it showed negative on the initial two lots and positive on the most recent third lot of the alere hcg test.The customer suspects that the patient had an ectopic pregnancy or had miscarried, but could not provide any further details.No treatments or procedures were performed on the basis of the false negative results.The patient was treated according to the serum quantitative result.Additional information: external controls were previously done with alere brand controls and were ok; internal control was showing up; sample was fresh and at room temperature for initial testing; no urinalysis was performed but the urine appeared normal and clear; no sample remains to return; test was read at 3 minutes using a timer.Technical services tried five times to obtain the lot number from the customer but was unsuccessful.Refer to mdr #2027969-201401059 for other lot number.
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