Abbott Laboratories recalls ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Read the official notice →- Date
- 2022-09-07
- Country
- United States
- Brand
- Abbott Laboratories
- Product
- ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
- Classification
- Class II
- Units
- Nationwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Abbott Laboratories recalls
- 2023-04-19
USAbbott Laboratories recalls Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
Potential of foreign material (hard plastic) within product
FDA · FoodAbbott LaboratoriesAL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO,…Official notice →- 2023-01-25
- US
Abbott Laboratories recalls Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Reaction vessels may contain a potential contaminant that could affect their optical performance.
FDA · DeviceAbbott LaboratoriesUS Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WVOfficial notice → - 2022-11-23
- US
Abbott Laboratories recalls Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Compromised seal integrity which could lead to spoilage
FDA · FoodAbbott LaboratoriesDomestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut,…Official notice → - 2022-08-31
- US
Abbott Laboratories recalls Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL…
Potential leaking/pinholes in bottle
FDA · FoodAbbott LaboratoriesDistributed to consignees in MD, NY, AL, FL, MA, NJ, and MIOfficial notice → - 2022-08-03
- US
Abbott Laboratories recalls REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
FDA · DeviceAbbott LaboratoriesUS: AK AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND…Official notice → - 2022-06-29
- US
Abbott Laboratories recalls Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT)…
These products are being recalled due to the potential of leakage from the 1L container.
FDA · FoodAbbott LaboratoriesAL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MI, MO, MS, NC, NH,…Official notice →
Other drugs & medical recalls in the United States
- 2022-09-07
- US
DeRoyal Industries Inc recalls DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Procedure packs contained a recalled product.
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of OH and TN.Official notice → - US
Corin Ltd recalls TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Some of the devices did not pass fatigue testing.
FDA · DeviceCorin LtdDistribution was made to NJ. There was no military/government distribution.Official notice → - US
Canon Medical System, USA, INC. recalls INFX-8000V. For radiographic and fluoroscopic studies and intervention.
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
- US
Qiagen Sciences LLC recalls FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the…
FDA · DeviceQiagen Sciences LLCIN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands,…Official notice → - US
New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin…
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
FDA · DeviceNew Standard Device IncU.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: NoneOfficial notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.…
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Austria,…Official notice →