The Recall Desk

Manufacturer

Alere Scarborough, Inc. dba Binax, Inc.

2 recalls in our database name Alere Scarborough, Inc. dba Binax, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2015-07-22

Of the 2 recalls from Alere Scarborough, Inc. dba Binax, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2095-2015·2015-07-22

    Alere i Influenza A & B Kit Recalled for False Negative Risk

    Alere is recalling 257 kits of the Alere i Influenza A & B test due to microbial growth that may cause false negative results.

    Product
    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 detecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2015·2015-06-03

    Alere i Influenza A & B kits recalled for false negative risk

    Alere Scarborough, Inc. is recalling specific lots of Alere i Influenza A & B kits due to a high invalid rate and increased risk of false negative results.

    Product
    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 inf
    Category
    Medical Device
    Distribution
    Distributed nationwide