FDA Medical Device Recalls (openFDA)
Altruan GmbH: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Recall number
- Z-1561-2026
- Recalling firm
- Altruan GmbH
- Product
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Status
- Open, Classified
- Initiated
- 2025-12-19
- Posted
- 2026-03-12
- Terminated
- not on file
- Reason
- Product not cleared by the FDA.
- Root cause
- No Marketing Application
- Action
- 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.
- Quantity
- 188 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model No. AL-42153; No UDI; Lot Code: 6952804827274.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GTY
- Firm FEI
- 3042770115
- Firm city
- Massing
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28