CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
InflammaDry MMP-9 Test recalled by Quidel
Quidel is recalling InflammaDry MMP-9 Test, distributed in 38 states. The recall was initiated on 5 Mar 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-1636-2024
- FDA event ID
- 94219
- Recalling firm
- Quidel, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Mar 2024
- FDA classified
- 24 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Device type
- Other Medical Devices
Timeline
| 5 Mar 2024 | Recall initiated by company | |
| 24 Apr 2024 | Classified by FDA | +50 days |
| 1 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Where it was distributed
US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NH NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI WV OUS: United Arab Emirates, Belgium, Canada, Chile, China, Germany, Spain, United Kingdom, Ireland, Italy, South Korea, Lithuania, Qatar
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
Which lots are affected?
UDI: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025
Where was it sold?
US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NH NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI WV OUS: United Arab Emirates, Belgium, Canada, Chile, China, Germany, Spain, United Kingdom, Ireland, Italy, South Korea, Lithuania, Qatar
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
1 other product · FDA event 94219This product is part of a recall event; the main page for the event is InflammaDry MMP-9 Test recalled by Quidel.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | InflammaDry MMP-9 Test recalled by Quidel | Quidel | Hidden Drug Ingredients | 38 states |
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|---|---|---|---|---|---|
| Device | CLASS II | QuickVue Dipstick Strep A Test, 50T recalled by Quidel | Quidel | Other | Nationwide |
| Device | CLASS II | QuickVue: Dipstick Strep A Test: 50T recalled by Quidel | Quidel | Other | Nationwide |
| Device | CLASS II | InflammaDry MMP-9 Test recalled by Quidel | Quidel | Hidden Drug Ingredients | 38 states |
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