Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37339 |
| Brand Name: | Clearview hCG Cassette and Innovacon hCG One Step Pregnancy Test Device |
| Model: | Clearview™ hCG Cassette (20 mIU/mL), Innovacon™ hCG One Step Pregnancy Test Device (Urine) |
| Affected: | Part number: 92210, FHC-102 - All lots within expiration date |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd Unit D 4 Pacific Rise Mt Wellington Auckland 2025 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Innovacon Inc |
| Issue: | Update 2/9/26: In consideration of the current market shortage of the affected products, this action has been revised for distributors. Distributors may continue to supply inventory to their customers, on the provision that all future customer orders must be accompanied by the Urgent Product Correction Customer Letter and Customer Reply Form. As part of routine post-market surveillance activities, an investigation was conducted into reports of false-positive results, and determined that while the tests demonstrate expected results at and above the established sensitivity levels, they may detect low levels of hCG below the stated assay sensitivity. This may result in false positive test results in samples from non-pregnant individuals. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 2/9/2026 |
