CLASS II Device recall · Reported 9 Aug 2017 · FDA Enforcement Report
InflammaDry(R) AN Rps Diagnostic Solution recalled by Quidel
Quidel is recalling InflammaDry(R) AN Rps Diagnostic Solution, Sample Collectors InflammaDry(R) is a rapid, distributed nationwide in the US. The recall was initiated on 22 Jun 2017 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-2803-2017
- FDA event ID
- 77640
- Recalling firm
- Quidel, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jun 2017
- FDA classified
- 1 Aug 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Jun 2017 | Recall initiated by company | |
| 1 Aug 2017 | Classified by FDA | +40 days |
| 9 Aug 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
Where it was distributed
Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TX, VA, WA, & WV.
Nationwide ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNebraskaNew HampshireNew Jersey
Questions about this recall
Is InflammaDry(R) AN Rps Diagnostic Solution, Sample Collectors InflammaDry(R) is a rapid recalled?
Yes. Quidel recalled InflammaDry(R) AN Rps Diagnostic Solution, Sample Collectors InflammaDry(R) is a rapid on 22 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-2803-2017.
Why was it recalled?
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Which lots are affected?
Lot numbers: 1705405, 1705359
Where was it sold?
Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TX, VA, WA, & WV.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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