On 08-mar-2024, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded positive results on a 28 year female patient.Return product is not available for investigation.Method; date, collected, tested, result, and sample.I-stat; (b)(6) 2024, immediately, 15:23, 39.3 iu/l, and a.Lab, (b)(6) 2024, 15:57, 18:54, <1, and b.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.I-stat positive cut-off values: b-hcg < 5.0 iu/l; negative.5.0 < ss-hcg < 25.0 iu/l; indeterminate.B-hcg >25.0 iu/l; positive.Intended use: the i-stat® total beta-human chorionic gonadotropin (b-hcg) test is an in vitro diagnostic test for the quantitative and qualitative determination of b-hcg in venous whole blood or plasma samples using the i-stat 1 analyzer systems.The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.
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