Remel, Inc recalls remel BactiDrop Acridine Orange, REF 21502, 50 per package.
A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Remel
- Product
- remel BactiDrop Acridine Orange, REF 21502, 50 per package.
- Classification
- Class II
- Units
- Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Remel recalls
- 2025-06-18
US
Remel, Inc recalls Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic…
Product may have an off color affecting perfomance
FDA · DeviceRemel, IncWorldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the…Official notice →- 2025-03-26
US
Remel, Inc recalls Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ…
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
FDA · DeviceRemel, IncDomestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH,…Official notice →- 2025-02-26
US
Remel, Inc recalls remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
- 2023-09-20
US
Remel, Inc recalls remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial…
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
- 2023-07-05
US
Remel, Inc recalls Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In…
The test medium may not perform as intended.
FDA · DeviceRemel, IncDistribution was made nationwide, including Puerto Rico. There was no foreign…Official notice →- 2022-12-14
US
Remel Inc recalls Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp.,…
Other drugs & medical recalls in the United States
- 2024-11-06
US
Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,…
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
FDA · DeviceSmith & Nephew IncUS Distribution to state of Texas and OUS (foreign) to countries of: Spain,…Official notice →US
King Systems Corp. dba Ambu, Inc. recalls AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent…
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
US
Nihon Kohden America Inc recalls Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
FDA · DeviceNihon Kohden America IncU.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT,…Official notice →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 →US
Olympus Corporation of the Americas recalls Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
US
Westmed, Inc. recalls 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders…
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.
FDA · DeviceWestmed, Inc.U.S.: AK, CA, CO, DC, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH,…Official notice →