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Recall Observatory FDA recall evidence

Device product

QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

Z-1636-2024

March 05, 2024

Class II

Product summary

Firm
Quidel Corporation
Event
Event 94219
Status
Ongoing
Classification
Class II
Quantity
104,300 units
Official record key
device-enforcement:Z-1636-2024

Official wording

Reason: 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.

Code information: UDI: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.