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95,018 total recalls in our database

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The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets bind and aggregate fibrinogen-coated beads. The instrument measures this change in optical signal and reports results in P2Y12 Reaction Units (PRU). The rate of microbead aggregation is more rapid and reproducible if platelets are activated; therefore, the reagent adenosine-5-diphosphate (ADP) is incorporated into the test channel to induce platelet activation. Prostaglandin E1 (PGE1) is included in the reagent mixture to increase the specificity of the PRU result to reflect P2Y12-mediated platelet aggregation. The reagents are formulated such to achieve reaction concentrations of 20 ¿M ADP and 22 nM PGE1. In a like manner, two other activators, iso-TRAP (Thrombin Receptor Activating Peptide) with PAR4-AP (PAR4-Activating Peptide) and fibrinogen-coated microparticles are incorporated into a second channel of the test device. The instrument measures the change in transmittance in this channel, calculates the baseline platelet function for the sample, and reports the percent inhibition result for the sample.

Accriva Diagnostics

🏥 Medical Devices Class I - Dangerous

Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.

Mar 30, 2022 Diagnostic Equipment Nationwide View Details →

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

Oct 22, 2021 Other Medical Devices View Details →

Wonder & Wise Activity Tables

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

Screws can become loose and/or detach from the xylophone component of the activity tables, posing a choking hazard to young children.

May 26, 2022 Furniture Nationwide View Details →

Children's pajamas

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The children's pajamas fail to meet the tight-fitting flammability standards for children's sleepwear, posing a risk of burn injuries to children.

May 26, 2022 Children's Products Nationwide View Details →

Children's pajamas

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.

May 26, 2022 Children's Products Nationwide View Details →

SE Grocers Cheesecake SAMPLER New York Style, Chocolate Silk, Strawberry Swirl, Turtle - NO ARTIFICIAL FLAVORS - NET WT 32 OZ (2 LB) 907g - UPC 0 38259 13495 5 CONTAINS: EGG, MILK, SOY, AND WHEAT. MANUFACTURED IN A FACILITY THAT ALSO PROCESSES PEANUTS, TREE NUTS (ALMONDS, COCONUT, PECANS, WALNUTS) DISTRIBUTED BY: SOUTHEASTERN GROCERS, 8928 PROMINENCE PKWY, BLDG 200, JACKSONVILLE, FL 32256

Atlanta Cheesecake Company

🍎 Food Class I - Dangerous

The firm was notified by a customer that the label does not declare pecans in its ingredient statement.

Apr 26, 2022 Dairy & Eggs View Details →