The Recall Desk

Manufacturer

Accumetrics Inc

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

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2014-03-19

Of the 4 recalls from Accumetrics 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-1172-2014·2014-03-19

    Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Erroneous Results

    Accumetrics is recalling VerifyNow IIb/IIIa test kits because they may report erroneous low platelet aggregation unit results, potentially affecting clinical decisions.

    Product
    VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0482-2014·2013-12-18

    Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Incorrect Instructions

    Accumetrics is recalling VerifyNow IIb/IIIa Test Kits because they contain incorrect instructions regarding the time limit for performing the test after sample collection.

    Product
    VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1854-2012·2012-06-27

    Accumetrics Recalls VerifyNow System for P2Y12 Test Result Changes

    Accumetrics is recalling 1,167 VerifyNow Systems to correct the P2Y12 test results by removing the BASE and % Inhibition values.

    Product
    VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1853-2012·2012-06-27

    Accumetrics Recalls VerifyNow P2Y12 Assay for Field Correction

    Accumetrics is recalling the VerifyNow P2Y12 Assay to implement a field correction that eliminates the reporting of BASE and % Inhibition results.

    Product
    VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for us
    Category
    Medical Device
    Distribution
    Distributed nationwide