CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report
Bisaf Strep A Self-Test recalled by Altruan
Altruan is recalling Bisaf Strep A Self-Test, distributed nationwide in the US. The recall was initiated on 19 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1561-2026
- FDA event ID
- 98472
- Recalling firm
- Altruan, Massing, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Dec 2025
- FDA classified
- 12 Mar 2026
- Reported
- 18 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Dec 2025 | Recall initiated by company | |
| 12 Mar 2026 | Classified by FDA | +83 days |
| 18 Mar 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product not cleared by the FDA.
Product as listed by the FDA
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Product not cleared by the FDA.
Which lots are affected?
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98472This product is part of a recall event; the main page for the event is Clearest Strep-A Cassette Test recalled by Altruan.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Clearest Strep-A Cassette Test recalled by Altruan | Altruan | Other | Nationwide | |
| CLASS II | Wondfo Streptococcal A At-Home Self-Test recalled by Altruan | Altruan | Other | Nationwide |
More recalls from Altruan
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Wondfo Streptococcal A At-Home Self-Test recalled by Altruan | Altruan | Other | Nationwide |
| Device | CLASS II | Clearest Strep-A Cassette Test recalled by Altruan | Altruan | Other | Nationwide |
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| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |