The US Food and Drug Administration (FDA) recalled Magellan Diagnostics’ LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests because of false low results and Abbott’s Alinity COVID-19 testing kits because of faulty reporting software. The FDA issued a Class I recall, which is the most serious type of recall for both laboratory testing devices. The CAP advocates for precise and safe diagnostic patient care.

Blood Lead Tests Recall

The blood lead testing devices were distributed from October 27, 2020 to August 19, 2021. These blood testing devices may cause serious patient harm because they might underestimate blood lead levels.

Additional LeadCare II products, including lots previously unaffected, were also recalled due to a significant risk of falsely low results. Go to the CDC’s website for recommendations on what should be done for these testing devices.

Pathologists and laboratories should continue to schedule and perform required blood lead tests for patients. A venous or capillary blood sample analyzed using higher complexity methods such as inductively coupled plasma mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectroscopy (GFAAS) from a CLIA compliant clinical laboratory should be used if LeadCare lead test kits are unavailable. Pathologists should always follow recommendations for best practices when collecting a capillary blood sample for lead testing.

Abbott COVID-19 Testing Kits Recall

The FDA also recalled Abbott’s Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096 due to false negative results and faulty reporting software. The false positive results may be related to current mixing parameters of the PCR reaction mixture that may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. The special processing equipment uses software to automate the mixing of the chemicals for the tests.

Go to the FDA’s website for recommendations on this specific recall.