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.,…
Read the official notice →- Date
- 2022-12-14
- Country
- United States
- Brand
- Remel
- Product
- Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
- Classification
- Class I
- Units
- US Nationwide Distribution
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-03-26
USRemel, 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.
- 2024-11-06
- US
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.
FDA · DeviceRemel, IncDistribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was…Official notice → - 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 → - 2022-03-16
- US
Remel Inc recalls Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
There are lower than expected MICs for some gram negative species.
Other drugs & medical recalls in the United States
- 2022-12-14
- US
Cardinal Health recalls Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the…
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of…
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers…
Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: AL, CA, FL, GA, IN, KY,…Official notice → - US
Caire, Inc. recalls CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
FDA · DeviceCaire, Inc.US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile,…Official notice → - US
DEWEI MEDICAL EQUIPMENT CO LTD recalls Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Products were distributed in the United States without FDA authorization or clearance.
FDA · DeviceDEWEI MEDICAL EQUIPMENT CO LTDUS Distribution in states to: CA, FL, KY, and MI.Official notice → - US
RemedyRepack Inc. recalls Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ…
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
FDA · DrugRemedyRepack Inc.Product was distributed to two different customers in MI.Official notice → - US
B. Braun Medical, Inc. recalls 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524…
Lack of sterility assurance: Bags have the potential to leak.