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U.S. Department of Health and Human Services

Class 2 Device Recall InflammaDry

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  Class 2 Device Recall InflammaDry see related information
Date Initiated by Firm June 22, 2017
Create Date August 01, 2017
Recall Status1 Terminated 3 on June 07, 2019
Recall Number Z-2803-2017
Recall Event ID 77640
510(K)Number K132066  
Product Classification MMP-9 test system - Product Code PFQ
Product 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.
Code Information Lot numbers: 1705405, 1705359
Recalling Firm/
Manufacturer
Quidel Corporation
10165 McKellar Ct
San Diego CA 92121-4201
For Additional Information Contact
858-552-1100 Ext. 7922
Manufacturer Reason
for Recall
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
FDA Determined
Cause 2
Process design
Action Quidel sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected customers. The notice instructed consignees to check inventory for affected lots (11705359 and 1705405), to remove and destroy any affected sample collectors from affected kits, and complete and return the attached Inventory Assessment/Certificate of Destruction form to Quidel by fax at 858-552-7905 or email to technicalsupport@quidel.com. Any questions by consignees should be directed to Quidel's Technical Support Team at 800-874-1517 or 858-552-1100, or by email at technicalsupport@quidel.com. It is requested that consignees keep recall notification and response in their records.
Quantity in Commerce 1078 kits, 21,560 sample collectors
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PFQ and Original Applicant = RAPID PATHOGEN SCREENING, INC.
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