Abbott Diagnostics Scarborough, Inc.
Scarborough, ME, US
Abbott Diagnostics Scarborough, Inc. appears in FDA device records in Scarborough, ME. FDA records list 7 510(k) clearances between and , 18 PMA records and 3 registered establishments. As of , FDA records show 22 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Abbott Diagnostics Scarborough, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Alere Scarborough, Inc. dba Binax, Inc.enforcement report, recall
- Binax, Inc.recall
- Binax, Inc. dba IMPDrecall
- Inverness Medical Professional Diagnostics510(k), recall
510(k) clearance history
FDA records hold 7 510(k) clearances for Abbott Diagnostics Scarborough, Inc. between 2007 and 2025. The busiest year on record is 2023, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250273 | BinaxNOW COVID-19 Ag Card | QVF | Substantially Equivalent | |
| K243518 | BinaxNOW™ COVID-19 Antigen Self Test | QYT | Substantially Equivalent | |
| K232775 | ID NOW Influenza A & B 2 | OCC | Substantially Equivalent | |
| K221925 | ID NOW COVID-19 2.0 | QWR | Substantially Equivalent | |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | OZE | Substantially Equivalent | |
| K191534 | ID NOW Influenza A & B 2 | OCC | Substantially Equivalent | |
| K070522 | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | MJH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221359 | 1221359 | Abbott Diagnostics Scarborough, Inc. | 10 Southgate Rd, Scarborough, ME 04074 US | 2026 | and 14 more, listed in full below |
| 3017662853 | 3017662853 | Abbott Diagnostics Scarborough, Inc. | 5 Bradley Dr, Westbrook, ME 04092 US | 2026 | and 2 more, listed in full below |
| 3029059580 | 3029059580 | Abbott Diagnostics Scarborough, Inc. | 65 Gannett Dr, Portland, ME 04106 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GTZAntisera, All Groups, Streptococcus Spp.
- QFAAssay For Detection Of Proteases In Chronic Wounds
- JBECell Enzymes (Erythrocytic And Leukocytic)
- QKPCoronavirus Antigen Detection Test System.
- LIBDevice, General Purpose, Microbiology, Diagnostic
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- OEMHuman Metapneumovirus (Hmpv) Rna Assay System
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
- MJZKit, Direct Antigen, Positive Control
- MJHLegionella, Spp., Elisa
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test
- QYTOver-The-Counter Covid-19 Antigen Test
- OAXPlasmodium Spp. Detection Reagents
- QSUPoint Of Care Hiv Serology Diagnostic And/Or Supplemental Test
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- OOIReal Time Nucleic Acid Amplification System
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- QWRSimple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
- MMWSystem, Test, Tumor Marker, Monitoring, Bladder
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1565-2026 | Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. | Class II | Open, Classified | |
| Z-1573-2025 | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Class II | Open, Classified | |
| Z-1572-2025 | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Class II | Open, Classified | |
| Z-1571-2025 | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Class II | Open, Classified | |
| Z-1576-2025 | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Class II | Open, Classified | |
| Z-1575-2025 | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Class II | Open, Classified | |
| Z-1574-2025 | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Class II | Open, Classified | |
| Z-2095-2015 | Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. | Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit | Class II | Terminated | |
| Z-1677-2015 | Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. | High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit. | Class II | Terminated | |
| Z-2501-2010 | UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy. | Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the UCG-Beta Slide Monoclonal II test. | Terminated | ||
| Z-2500-2010 | UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy. | Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the UCG-Beta Slide Monoclonal II test. | Terminated | ||
| Z-1506-2009 | Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic. | Potential for false positive Strep A results. | Terminated | ||
| Z-0826-2007 | BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper | Tip of the foam swab could detach from the shaft causing injury to the patient. | Terminated | ||
| Z-0825-2007 | BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labeled on the swab wrapper | Tip of the foam swab could detach from the shaft causing injury to the patient. | Terminated | ||
| Z-0824-2007 | BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper | Tip of the foam swab could detach from the shaft causing injury to the patient. | Terminated | ||
| Z-0823-2007 | BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper | Tip of the foam swab could detach from the shaft causing injury to the patient. | Terminated | ||
| Z-0822-2007 | BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper | Tip of the foam swab could detach from the shaft causing injury to the patient. | Terminated | ||
| Z-0594-2007 | Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes Wampole Laboratories Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia. | Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off. | Terminated | ||
| Z-0222-2007 | NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000 | Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches | Terminated | ||
| Z-0780-04 | NOW Malaria (Export use only) Item Number 660-430, Kit Number 66005, Kit Number 660-000 | Pouch integrity compromised | Terminated | ||
| Z-0779-04 | NOW Filariasis Rapid test for W. bancrofti antigen. (Export use only) Item Number 620-430, Kit Number 620-000, | Pouch integrity compromised | Terminated | ||
| Z-0778-04 | NOW RSV Test Item Number 430-430, Kit Number 430-00R | Pouch integrity compromised | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain