Parasite tests, SKU 2A178, recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 94 units of its Parasite Test because the product was distributed without premarket approval or clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a premarket clearance shortfall with no stated product defect, consequence or reported harm.
Plain-English summary
The Parasite Test from Get Tested International AB is being recalled. The product is identified by EAN 616612786425 and SKU 2A178, and the recall covers all lots.
The reason given in the enforcement record is distribution without premarket approval or clearance.
The record lists a quantity of 94 units, distributed nationwide in the United States. The FDA has classified the action as Class II.
The record describes a regulatory clearance issue rather than a specific product defect, and states no injuries. Customers should follow the firm's instructions.
The recalled product
- Product
- Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
- Manufacturer
- Philips Ultrasound, LLC
- Category
- Medical Device — Diagnostic test
- Affected units
- 4,819
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI:700884838103405
- 00884838120266
- 00884838064713
Distribution
Related recalls
Same manufacturer · Philips Ultrasound, LLC
See all →- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
- ModerateUltrasound systems recalled over unexpected reboots that damage the transducer
FDA (Devices) · 2026-01-07
Same hazard · unapproved device
See all →- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateOne Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13
Similar recalls
- ModerateParasite tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateCandida test kits, SKU 2A120, recalled for lacking premarket clearance
FDA (Devices) · 2025-12-10
- ModerateLyme tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModeratePet allergy tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateSyphilis tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateLeaky gut tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10