Medical device test system recalled for decreased reactivity and false-negative results
Greer Laboratories recalled a hypersensitivity pneumonitis test kit (102 units, Lot 389592) after stability testing revealed decreased reactivity that could cause false-negative results. The issue was discovered in October 2021.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a diagnostic test system where decreased reactivity could produce false-negative test results. No illnesses or injuries have been reported. The product represents a risk-of-harm scenario where injury has not yet occurred, meeting the criteria for severity level 3.
Plain-English summary
Greer Laboratories, Inc. is recalling one lot of its GREER DIA - KIT ANTIGEN M. FAENI, an analyte-specific reagent used in a gel diffusion test system for detecting hypersensitivity pneumonitis. The recalled lot (389592, expiring 6/12/2023) contains 102 units and was distributed to healthcare facilities in 12 U.S. states (CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA) and internationally to Canada and Denmark.
The recall was initiated because stability evaluation indicated a decrease in reactivity of the test material. This decreased reactivity could lead to false-negative test results, meaning that patients with hypersensitivity pneumonitis could receive negative results despite having the condition. The issue was discovered on October 8, 2021 after the lot failed to meet potency requirements during a 6-month stability evaluation. A subsequent manufacturing investigation found that the initial lot release potency test had been misinterpreted.
Healthcare providers should identify and review any test results generated from this lot. Patients who received testing from this lot should consult with their healthcare provider about whether retesting is appropriate.
The recalled product
- Product
- GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
- Manufacturer
- Greer Laboratories, Inc.
- Hazard
- false-negative-result
- decreased-reactivity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 389592
- exp 6/12/2023
Distribution
Distributed in 11 states:
- CA
- CO
- IA
- KY
- MA
- MD
- MO
- NC
- PA
- UT
- VA
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