Becton Dickinson & Co. recalls BD PCR Cartridges used with MAX System. Model Number: 437519
Potential for signal drift in specific lots of BD PCR Cartridges.
Read the official notice →- Date
- 2025-01-29
- Country
- United States
- Brand
- Becton Dickinson &
- Product
- BD PCR Cartridges used with MAX System. Model Number: 437519
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Becton Dickinson & recalls
- 2025-07-30
US
Becton Dickinson & Co. recalls BD COR System Software. Model Number: 444829.
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
FDA · DeviceBecton Dickinson & Co.Worldwide - US Nationwide distribution in the states of Florida, Texas and…Official notice →- 2025-07-02
US
Becton Dickinson & Co. recalls BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to…
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE,…Official notice →- 2025-03-12
US
Becton Dickinson & Co. recalls BD BBL TB Stain Kit K, Catalog (REF): 212522
One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
FDA · DeviceBecton Dickinson & Co.Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA.…Official notice →- 2024-12-11
US
Becton Dickinson & Co. recalls BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro…
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin…
FDA · DeviceBecton Dickinson & Co.Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA,…Official notice →US
Becton Dickinson & Co. recalls BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is…
FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice →- 2024-10-16
US
Becton Dickinson & Co. recalls BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution…
Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have…
FDA · DeviceBecton Dickinson & Co.Nationwide Foreign: Australia, New Zealand, Singapore, Hong Kong, Taiwan,…Official notice →
Other drugs & medical recalls in the United States
- 2025-01-29
US
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914…
The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →US
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified),…
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →US
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415…
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →US
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm,…
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution and International: Algeria, Armenia, Australia,…Official notice →US
MICROVENTION INC. recalls Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
US
St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care…
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
FDA · DeviceSt. Jude MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →