The Recall Desk

Manufacturer

Accelerate Diagnostics Inc

4 recalls in our database name Accelerate Diagnostics Inc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2022-12-07

Of the 4 recalls from Accelerate Diagnostics 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.

1–4 of 4

  • HighFDA (Devices)·Z-0345-2023·2022-12-07

    Accelerate PhenoTest BC Kit Recall Due to False Positive Bacterial Identification

    Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.

    Product
    Accelerate PhenoTest BC kit REF 10101018
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0346-2023·2022-12-07

    Diagnostic Kit Recalled for False Positive Bacterial Identification Results

    Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.

    Product
    Accelerate PhenoTest BC kit REF 10102018
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1065-2019·2019-04-03

    Accelerate Pheno System Recalled for Incorrect Meropenem Susceptibility Results

    Accelerate Diagnostics is recalling 81 Accelerate Pheno systems because rare bacterial isolates may generate incorrect meropenem susceptibility results. A software update suppresses these specific results to mitigate risk.

    Product
    Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse da
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2018·2018-05-02

    Accelerate PhenoTest BC kit recalled for false positive results

    Accelerate Diagnostics is recalling 95 PhenoTest BC kits because they may produce false positive results for Staphylococcus aureus.

    Product
    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
    Category
    Medical Device
    Distribution
    5 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Accelerate Diagnostics

diagnostics company

Country
United States
Founded
1987

Official website

Source: Wikidata (Q91490380), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.