Genetic Testing Institute Recalls PF4 Concentrated Wash Reagent Lots
Genetic Testing Institute is recalling specific lots of PF4 Concentrated Wash (10x) because the reagent is slightly more dilute than intended, which may cause false positive test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential false positive results due to reagent dilution, which is a quality issue without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or labeling/quality errors.
Plain-English summary
Genetic Testing Institute, Inc. is recalling specific lots of PF4 Concentrated Wash (10x), Reference 403624. This reagent is packaged in ImmucorGamma LIFECODES PF4 IgG and PF4 Enhanced assay kits. The recall covers 6,206 kits distributed nationwide in the United States and internationally to Canada, Japan, Belgium, the European Union, Australia, Taiwan, Thailand, and Scotland.
The recall was initiated because the affected lots of PF4 Concentrated Wash are a slightly more dilute concentration than intended. This dilution may lead to slightly increased Optical Density (OD) values, causing samples with higher background reactivity to demonstrate false positive results (borderline reactivity) at or near the assay cutoff.
The affected reagent lot numbers are 3001620, 3001987, 3002083, and 3002153. Users of these assay kits should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked…
- Manufacturer
- Genetic Testing Institute,inc
- Affected units
- 6,206
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 (4)
- Reagent Lot Numbers: 3001620
- 3001987
- 3002083
- 3002153
Distribution
Related recalls
Same manufacturer · Genetic Testing Institute,inc
See all →- ModerateGenetic Testing Institute Recalls PF4 Enhanced Assay Kits Due to Invalid Results
FDA (Devices) · 2013-04-03
Same hazard · false positive result
See all →- ModerateAlere Recalls hCG Pregnancy Tests Due to False Positive Risk
FDA (Devices) · 2026-10-07
- ModerateAlere hCG Urine Test Strips Recalled for False Positive Risk
FDA (Devices) · 2026-10-07
- HighAlere hCG Pregnancy Test Cassettes Recalled for False Positive Results
FDA (Devices) · 2026-10-07
- HighSequencing Agent SEQ0067 Component Recalled for Potential False-Positive Results
FDA (Devices) · 2026-04-29
- HighStratus CS Acute Care cTNI TestPak cardiac troponin test recall
FDA (Devices) · 2025-05-07
Similar recalls
- ModerateGenetic Testing Institute Recalls PF4 Enhanced Assay Kits Due to Invalid Results
FDA (Devices) · 2013-04-03
- ModerateBinding Site IgG4 Reagent Kits Recalled for Inaccurate Results
FDA (Devices) · 2017-02-01
- ModerateAbbott C4 In Vitro Diagnostic Assay Recall for Instruction Manual Updates
FDA (Devices) · 2019-07-31
- LowSiemens N Latex IgM Reagent Recalled for Proficiency Testing Failures
FDA (Devices) · 2015-03-25
- ModerateBinding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results
FDA (Devices) · 2017-02-01
- ModerateAbbott Immunoglobulin G Diagnostic Assay Recall for IFU Updates
FDA (Devices) · 2019-07-31