Qualigen Inc recalls FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.
Read the official notice →- Date
- 2024-10-16
- Country
- United States
- Brand
- Qualigen
- Product
- FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
- Classification
- Class II
- Units
- US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Qualigen recalls
- 2025-01-15
US
Qualigen Inc recalls The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and…
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The…
FDA · DeviceQualigen IncDistribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN,…Official notice →
Other drugs & medical recalls in the United States
- 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 →US
Atrium Medical Corporation recalls iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the states of FL, MA, MI, OH, WA.Official notice →US
Howmedica Osteonics Corp. recalls Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and…
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
FDA · DeviceHowmedica Osteonics Corp.US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI.…Official notice →US
Stryker Neurovascular recalls The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end…
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed…
FDA · DeviceStryker NeurovascularU.S. Nationwide distribution in the states of CA and VA.Official notice →US
Philips North America Llc recalls IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:…
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices.…
FDA · DevicePhilips North America LlcForeign Only: Denmark France Germany Japan United KingdomOfficial notice →US
Zyno Medical LLC recalls Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and…
There is a defect in the air-in-line software algorithm.