The U.S. Food and Drug Administration (FDA) issued class I recalls for two medical devices, the StatStrip Glucose Hospital Meter System (Gen 2.0) by Nova Biomedical and the HemosIL AcuStar HIT-IgG(PF4-H) assay by Instrumentation Laboratory (Werfen).

These recalls highlight different risks to patient safety. The StatStrip glucose meter could cause incorrect patient information to be recorded in the patient’s medical records. The HemosIL AcuStar assay has specific batches which may cause false negatives for the diagnosis of heparin-induced thrombocytopenia (HIT) due to issues in performance.

Class 1 recalls are issued where it is considered there is a reasonable probability that serious adverse health consequences or death may result from the use of the product.

The FDA has indicated that there was a scanning issue with the StatStrip Glucose Hospital Meter System by Nova Biomedical Gen 2.0.

Previously scanned patient or quality control (QC) barcodes could appear on the meter. If healthcare workers do not realise and select ‘Okay’ then incorrect blood glucose values could be recorded in the wrong patient or QC record within the electronic medical record (EMR).

This could impact the accuracy of the information within the patient’s records.

Potential Risk to Patients

Incorrect recording of a patient's glucose levels could cause incorrect decisions to be made by healthcare professionals.

If patients had incorrect glucose levels recorded then decisions surrounding insulin and glucose correction could be made. This could cause delays in identifying and managing hypoglycaemia or hyperglycaemia.

The FDA also identifies critically ill patients and infants as being at greater risk of adverse outcomes. Infants, in particular, may be unable to communicate symptoms of hypoglycaemia, making accurate patient identification and glucose records particularly important.

Nova Biomedical has reported 1 serious injury to a patient as of 5 October, 2026. However, there have been no deaths related to the issue.

What Should Hospitals Do About the StatStrip Recall?

The FDA recommends extra precautions are taken whilst waiting for the software update.

Ensure patient identification is correct. If you have admission, discharge, transfer (ADT) integrated systems ensure the NovaNet settings are set to "Validate Patient ID's".

Set automatic log off. Within NovaNet change the settings to automatic log off after each test has been performed by selecting ‘Test’ under the Operator Logoff Mode.

Verify patient identification. Healthcare workers should check the patient ID appears correctly once the barcode has been scanned and once the glucose result is shown.

If possible, the FDA recommends that hospitals stop using the Gen 2.0 devices until the software update is available. If they are unable to stop using them, they should follow the recommendations above.

Nova Biomedical has implemented a shipment hold on new StatStrip Glucose Hospital Meter Systems (Gen 2.0) while corrective actions are being developed and validated. The company intends to roll out a software update in November 2026 in phases.

This does not affect previous versions of the StatStrip Glucose Hospital Meter.

Also Read: FDA Issues Early Alert and Recall Notice for Philips Lumify Ultrasound Systems After Four Deaths and Eight Serious Injuries

The second device to be recalled was 4 batches of the HemosIL AcuStar HIT-IgG(PF4-H) assay by Instrumentation Laboratory (Werfen).

This is a fully automated chemiluminescence immunoassay used to detect IgG antibodies which bind to platelet factor 4 (PF4) when complexed with heparin. It helps healthcare professionals assess the risk of HIT when combined with other laboratory results and patient information.

The FDA has indicated that the affected batches showed a negative bias of ~20-35%. One customer complaint indicated that the mean bias was -47% for patient samples.

The manufacturer identified that this issue could not always be detected using standard calibration and quality control.

The root cause of the assay performance issue remains under investigation. The FDA also reported that the manufacturer identified invalid calibration curves in customer complaints.

Indian Distribution

India is among the countries listed in the FDA's distribution records for the affected Werfen products. The FDA recall record identifies worldwide distribution, including India, and lists all four affected batches. Werfen also lists the AcuStar HIT-IgG(PF4-H) assay on its official Indian website through Instrumentation Laboratory India Pvt Ltd.

However, the FDA's distribution record does not identify the individual Indian hospitals or laboratories that received the affected batches.

Potential Risk to Patients

The main risk is providing false negatives for HIT.

HIT is an immune mediated adverse effect caused by exposure to heparin. Antibodies are produced against PF4-heparin complexes which can activate platelets and cause potentially life threatening thrombosis.

The negative bias in the recalled batches could cause patient results to be less than the cut off value of 1.00 U/mL. This could cause a sample from a patient with HIT to show as negative.

This could cause delays in diagnosing HIT and influence decisions made by healthcare professionals. If HIT is not recognised the continued exposure to heparin could increase the risk of thrombosis such as deep vein thrombosis, and pulmonary embolism.

As of 3 September, 2026 no serious injuries or deaths were reported by the manufacturer.

What Should Laboratories Do About the Werfen Recall? 

The FDA has have recommended that laboratories and healthcare facilities;

Identify and dispose of any remaining stock from the 4 affected batches following your facilities procedures. 

Record the amount disposed of and date using the manufacturer’s Urgent Mandatory Response Tracking Form.

Identify alternative methods of testing for HIT antibodies.

Decisions around previous patient results should be made by the laboratory and clinicians.

For Indian laboratories seeking clarification, Werfen's official Indian website lists Instrumentation Laboratory India Pvt Ltd, with the following contact details:

• Email: info-in@werfen.com

• Telephone: +91 124 6939550

Also Read: RML Medicine Recall: What Patients Need to Know as 10 Critical Drug Batches Fail Quality Checks

Implications for Healthcare Facilities

Both of these recalls demonstrate issues with the processes used in testing. The StatStrip issue demonstrates how incorrect patient identification and data integration can cause issues with point-of-care testing. Whilst the HemosIL AcuStar issue shows how variation in assay performance can impact clinical decisions.

Overall, this demonstrates the importance of ensuring patient identification processes are in place, equipment is monitoring and checking diagnostic stock levels. This will ensure manufacturers and regulatory bodies recommendations are followed in a timely manner.

Both situations also demonstrate the importance of ensuring that medical devices are safe. This is not only about ensuring that tests are accurate but also that patient safety is ensured through correct identification, accurate interpretation and appropriate actions.

References:

1. U.S. Food and Drug Administration. “Hospital Glucose Meter Correction: Nova Biomedical Updates Use Instructions for StatStrip Glucose Hospital Meter Systems.” October 30, 2026. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/hospital-glucose-meter-correction-nova-biomedical-updates-use-instructions-statstrip-glucose 

2. U.S. Food and Drug Administration. “Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H).” October 30, 2026. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/platelet-factor-4-pf4-radioimmunoassay-recall-instrumentation-laboratories-removes-hemosil-acustar 

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