Z-2803-2017Class II

InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for...

Name: Z-2803-2017 InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for...
Creator: Quidel Corporation
Published: 2017-06-22
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-06-22 / Terminated / root cause: manufacturing process

FDA source

Quidel Corporation began a recall of InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of... on 2017-06-22. FDA classified it as Class II and gives the reason as "In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2803-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-22
Posted: 2017-08-01
Terminated: 2019-06-07
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: PFQ Mmp-9 Test System
Reason for recall: In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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 [email protected]. 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.
Product codes and lots: Lot numbers: 1705405, 1705359

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2803-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2803-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-08-01

Product code PFQ

K132066Class IInflamma DryRapid Pathogen Screening, Inc. / cleared 2013-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)