# FDA 483 - Abbott Diagnostics Scarborough, Inc. - March 02, 2018

Source: https://www.globalkeysolutions.net/records/483/abbott-diagnostics-scarborough-inc/afcdce87-41b8-4e97-959e-259375e2fc16

> FDA 483 for Abbott Diagnostics Scarborough, Inc. on March 02, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Diagnostics Scarborough, Inc.
- Inspection Date: 2018-03-02
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Alere Scarborough, Inc. in Scarborough, ME, was cited for significant deficiencies in its Medical Device Reporting (MDR) processes during an FDA inspection. The firm failed to submit timely MDRs for false positive and false negative results from its Alere Determine HIV-1/2 Ag/Ab Combo assay, which could cause or contribute to serious injury or death. Additionally, the company's written MDR procedure was found to be inadequate for identifying and evaluating reportable events.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marlene-l-davis/3443354d-c5b2-4515-9fa6-9037d65a895f)
- [Engineer/Investigator](https://www.globalkeysolutions.net/people/elizabeth-b-griffin/5567685a-c657-4710-afee-e7af8875b605)

Company: https://www.globalkeysolutions.net/companies/abbott-diagnostics-scarborough-inc/de5ed379-275c-4281-acd5-e6ffd92017a9

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7