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Lower risk Medical device recall · FDA · Published May 20, 2025

BD BACTEC MGIT 960 PZA Kit Recall: False Resistance Results in TB Testing

Becton Dickinson recalls BD BACTEC MGIT 960 PZA Kit due to intermittent false resistance results for pyrazinamide in Mycobacterium tuberculosis susceptibility testing. Affected lots include 4150998, 4177908, and others.

🇺🇸 FDA recall #Z-2023-2025Medical deviceBecton Dickinson ›
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Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212
✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kits that may give false resistance results for pyrazinamide in tuberculosis testing. This could lead to incorrect treatment decisions for TB patients. Users should check their lot numbers to see if they are affected. Read more at govinfonow.com/recall/52253-bd-bactec-mgit-960-pza-kit-recall-false-resistance-results.

Source Summary by GovInfoNow · govinfonow.com/recall/52253-bd-bactec-mgit-960-pza-kit-recall-false-resistance-results · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2023-2025

Cite this page

“BD BACTEC MGIT 960 PZA Kit Recall: False Resistance Results in TB Testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52253-bd-bactec-mgit-960-pza-kit-recall-false-resistance-results. Based on FDA recall #Z-2023-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2023-2025%22&limit=1).

The FDA announced on May 20, 2025, that Becton Dickinson & Co. is voluntarily recalling the BD BACTEC MGIT 960 PZA Kit due to intermittent false resistance results for pyrazinamide during susceptibility testing of Mycobacterium tuberculosis isolates.

How to tell if you have it

  • Brand: Becton Dickinson
  • Product: BD BACTEC MGIT 960 PZA Kit
  • Catalog No.: 245128
  • UDI-DI: (01) 0038290245128
  • Lot Nos.: 4150998, 4177908, 4178500, 4262031, 4262036, 4262037, 4262039, 4262040, 4262044, 4284438, 4284441, 4284443, 4284445, 4284449, 4304789, 4304796, 4347228, 4347230, 4352110, 4362418, 5007456, 5020153, 5050670, 5050671, 5050672, 5050675, 5050678
  • Units affected: 12,256 eaches

The hazard

The FDA stated that Becton Dickinson has received additional complaints of intermittent false resistance results for pyrazinamide during susceptibility testing of Mycobacterium tuberculosis isolates.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Other recent recalls include the BD GasP: CO2 Pouch System Recall (April 7, 2026), the BD Kiestra Isolate Suspension Cuvette Array Recall (Oct. 23, 2025), and the BD BACTEC Blood Culture System Recall (Sept. 23, 2025). Other recent recalls of similar products include the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), the Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and the HardyDisk AST Cefiderocol 30μg FDC30 Recall (June 8, 2026).

How to tell if you have this one

Check the lot number on the kit's packaging. Affected lots include 4150998, 4177908, 4178500, 4262031, and others listed in the recall notice.

  • Brand
    Becton Dickinson
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Lot Number

    Look for the lot number on the packaging to determine if it is affected. Affected lots include 4150998, 4177908, 4178500, 4262031, and others listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE, BN, BR, CA, CN, CR, DO, GT, HK, HT, ID, IN, JP, KH, KR, MO, MX, MY, NP, NZ, PE, PH, PK, SG, SV, TH, TW, VN.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: May 20, 202512. FDA classified it Class II: Jun 25, 202523. Published in FDA’s Enforcement Report: Jul 2, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What lot numbers are affected?

Affected lots include 4150998, 4177908, 4178500, 4262031, 4262036, 4262037, 4262039, 4262040, 4262044, 4284438, 4284441, 4284443, 4284445, 4284449, 4304789, 4304796, 4347228, 4347230, 4352110, 4362418, 5007456, 5020153, 5050670, 5050671, 5050672, 5050675, 5050678.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2023-2025 (May 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2023-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA