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Unrated Medical device recall · FDA · Published July 26, 2019

BD Kiestra InoqulA+ Software 20.3 Recall: Risk of Specimen-Plate Mismatch

Becton Dickinson recalls BD Kiestra InoqulA+ software version 20.3 for potential specimen-plate mismatch. Affected units have specific catalog and serial numbers. No remedy is stated in the recall notice.

🇺🇸 FDA recall #Z-2439-2019Medical 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 software version 20.3 for their Kiestra InoqulA+ system due to a potential mismatch between specimens and plates. This could lead to incorrect test results if the software fails to properly match samples to the correct testing plates. Read more at govinfonow.com/recall/67319-bd-kiestra-inoqula-software-20-3-recall-risk-of-specimen.

Source Summary by GovInfoNow · govinfonow.com/recall/67319-bd-kiestra-inoqula-software-20-3-recall-risk-of-specimen · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2439-2019

Cite this page

“BD Kiestra InoqulA+ Software 20.3 Recall: Risk of Specimen-Plate Mismatch.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67319-bd-kiestra-inoqula-software-20-3-recall-risk-of-specimen. Based on FDA recall #Z-2439-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2439-2019%22&limit=1).

The Food and Drug Administration announced on July 26, 2019, that Becton Dickinson & Co. is recalling BD Kiestra InoqulA+ Software Version 20.3 due to an anomaly that may cause a mismatch between a specimen and plate. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Becton Dickinson
  • Product: BD Kiestra InoqulA+ Software Version 20.3
  • Catalog Number: 447213
  • Serial Numbers/UDIs: INO-000290 00382904472139, INO-000263 00382904472139, INO-000264 00382904472139, 20130276 00382904472139, INO-000282 00382904472139, INO-000284 00382904472139, INO-000272 00382904472139, INO-000274 00382904472139
  • Units affected: 9

The hazard

According to the FDA, an anomaly in InoqulA / InoqulA+ software version 20.3 has the potential to cause a mismatch between a specimen and plate.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Recent recalls include the BD GasPak EZ Campy Pouch System Recall for low CO2 levels (April 7, 2026) and the BD Kiestra Isolate Suspension Cuvette Array recall for barcode errors (Oct. 23, 2025). Other recent recalls of similar products include Becton Dickinson 10mL Non-Sterile Luer-Lok Syringes recalled due to wrong syringe type (Jan. 27, 2026) and the Becton Dickinson Spinal Tray recall for quality issues from FDA inspection (April 27, 2026).

How to tell if you have this one

Check for catalog number 447213 and specific serial numbers listed in the recall notice. The affected software version is 20.3 for BD Kiestra InoqulA+ systems.

  • Brand
    Becton Dickinson
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
Recall numberProduct, codes & lotsQuantity
Z-2438-2019BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202; Catalog Number: 447202 Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 003829044720234 units
Z-2439-2019BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213; Catalog Number: 447213 Serial Number/UDI: INO-000290 00382904472139 INO-000263 00382904472139 INO-000264 00382904472139 20130276 00382904472139 INO-000282 00382904472139 INO-000284 00382904472139 INO-000272 00382904472139 INO-000274 003829044721399 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your BD Kiestra InoqulA+ system. If it is version 20.3, it is affected.

Where it went and when

Where it was distributed

Distributed in 6 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, Iowa, Missouri, New York, Ohio, Tennessee.

Recall timeline

FDA terminated this recall 4 months after the firm started it.

1. Firm started the recall: Jul 26, 201912. FDA classified it Class II: Aug 30, 201923. Published in FDA’s Enforcement Report: Sep 11, 201934. FDA terminated the recall: Dec 6, 201942019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-2439-2019 (July 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2439-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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