Altruan GmbH recalls Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci…
Reason for recall
Product not cleared by the FDA.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samplesAffected lot01242573
What the firm is doing
The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1560-2026
- FDA device classification · GTYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 866.3740The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Altruan GmbHSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP)
The potential for falsely elevated results.
- C-Reactive Protein Test System
- Under Investigation by firm
Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the pl…
- Bone Fixation Plate
- Process control
Karl Storz Endoscopy recalls HOPKINS Telescope 30¿
Due to incorrect inside packaging label for eyepiece.
- Nasopharyngoscope (Flexible Or Rigid)
- Employee error