CLASS II ONGOING Device recall · Reported 19 Jun 2024 · FDA Enforcement Report
Independent Medical Co-op Inc. recalled by Wondfo USA Co
Wondfo USA is recalling Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A, distributed nationwide in the US. The recall was initiated on 22 Apr 2024 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-2033-2024
- FDA event ID
- 94261
- Recalling firm
- Wondfo USA, Willowbrook, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2024
- FDA classified
- 7 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 22 Apr 2024 | Recall initiated by company | |
| 7 Jun 2024 | Classified by FDA | +46 days |
| 19 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Product as listed by the FDA
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
Where it was distributed
US Nationwide distribution.
Stores named: Online Retailers
Questions about this recall
Why was it recalled?
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Which lots are affected?
Lot Numbers: W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, W03921007
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
4 other products · FDA event 94261This product is part of a recall event; the main page for the event is Preview Strep A, Streptococcal A rapid test kits recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Preview Strep A, Streptococcal A rapid test kits recalled | Wondfo USA | Other | Nationwide | |
| CLASS II | Clarity and Clarity Diagnostics LLC recalled by Wondfo USA Co | Wondfo USA | Other | Nationwide | |
| CLASS II | Streptococcal A rapid test kits, labeled as recalled by Wondfo USA Co | Wondfo USA | Other | Nationwide | |
| CLASS II | Streptococcal A rapid test kits, labeled as recalled by Wondfo USA Co | Wondfo USA | Other | Nationwide |
More recalls from Wondfo USA
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Streptococcal A rapid test kits, labeled as recalled by Wondfo USA Co | Wondfo USA | Other | Nationwide |
| Device | CLASS II | Streptococcal A rapid test kits, labeled as recalled by Wondfo USA Co | Wondfo USA | Other | Nationwide |
| Device | CLASS II | Clarity and Clarity Diagnostics LLC recalled by Wondfo USA Co | Wondfo USA | Other | Nationwide |
| Device | CLASS II | Preview Strep A, Streptococcal A rapid test kits recalled | Wondfo USA | Other | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |