Beckman Coulter, Inc. recalls The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human…
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
Read the official notice →- Date
- 2024-10-23
- Country
- United States
- Brand
- Beckman Coulter
- Product
- The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Beckman Coulter recalls
- 2024-11-13
USBeckman Coulter, Inc. recalls The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels…
The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot…
- 2024-11-06
- US
Beckman Coulter, Inc. recalls Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access…
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
FDA · DeviceBeckman Coulter, Inc.Distribution was made nationwide to the U.S., including Puerto Rico. There was…Official notice → - 2024-10-23
- US
Beckman Coulter Inc. recalls IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry…
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
FDA · DeviceBeckman Coulter Inc.U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.:…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with…
- 2024-10-16
- US
Beckman Coulter, Inc. recalls Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative,…
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator…
FDA · DeviceBeckman Coulter, Inc.Distribution was made to FL, GA, IN, KS, NH, NJ, OK, PA, and TX. There was…Official notice → - 2024-09-25
- US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro…
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2024-10-23
- US
Beckman Coulter Inc. recalls IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry…
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
FDA · DeviceBeckman Coulter Inc.U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.:…Official notice → - US
Spineology, Inc. recalls The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access…
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
- US
Boston Scientific Corporation recalls Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an…
Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in Puerto Rico.Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with…
- US
CUE HEALTH INC recalls Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
- US
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2;…
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause…