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Lower risk Medical device recall · FDA · Published May 24, 2019

Abbott ARCHITECT BNP Calibrators: Stability drift risks inaccurate test results

Abbott recalls ARCHITECT BNP Calibrators due to stability drift causing inaccurate BNP test results. Affected units include specific lot numbers from July 2019 to January 2020. Consumers should contact Abbott for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2078-2019Medical deviceAbbott ›
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Contact the company

Recalling firmAbbott Laboratories100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL 60064-3502
✎ GovInfoNow plain-language explainer

What happened, in plain English

Abbott is recalling ARCHITECT BNP Calibrators because they can cause inaccurate blood test results over time. This affects laboratory equipment used for measuring BNP levels in patients. Using these calibrators without correction could lead to incorrect health diagnoses. Read more at govinfonow.com/recall/67867-abbott-architect-bnp-calibrators-stability-drift-risks-inaccurate-test-results.

Source Summary by GovInfoNow · govinfonow.com/recall/67867-abbott-architect-bnp-calibrators-stability-drift-risks-inaccurate-test-results · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2078-2019

Cite this page

“Abbott ARCHITECT BNP Calibrators: Stability drift risks inaccurate test results.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67867-abbott-architect-bnp-calibrators-stability-drift-risks-inaccurate-test-results. Based on FDA recall #Z-2078-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2078-2019%22&limit=1).

Why it’s dangerous

The calibrators can develop a time-dependent stability drift, meaning test results become less accurate over time. This drift causes patient and control results to shift, potentially leading to incorrect BNP measurements. The issue occurs in the calibration process for blood tests.

Who’s affected

Laboratories using Abbott's ARCHITECT BNP Calibrators for blood tests are affected. Patients receiving results from these calibrators may be at risk of incorrect diagnoses.

How to tell if you have this one

Check for lot numbers listed in the recall: 44K79318 (23JUL2019), 44K80818 (05SEP2019), 44K82118 (09OCT2019), 44K82618 (15NOV2019), 44K85119 (22JAN2020), and 44K79418 (23JUL2019), 44K81018 (05SEP2019), 44K82018 (09OCT2019), 44K85219 (22JAN2020).

  • Brand
    Abbott
  • Product
    ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem
  • 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 III
  • Status
    Terminated
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed worldwide to ALGERIA, ANDORRA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVI, BRUNEI, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CROATIA, CURACAO, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GREENLAND, HONDURAS, HUNGARY, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, KYRGYZSTAN, LEBANON, LITHUANIA, LUXEMBOURG, MACEDONIA, MALDIVES, MALI, MAURITANIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TANZANIA, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UNITED KINGDOM, VIETNAM, ZIMBABWE.
Recall numberProduct, codes & lotsQuantity
Z-2078-2019ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.; a. List Number 8K2802 - Lot Number (Expiration Date) UDI: 44K79318 (23JUL2019) (01)00380740017460(17)190723(10)44K79318, 44K80818 (05SEP2019) (01)00380740017460(17)190905(10)44K80818, 44K82118 (09OCT2019) (01)00380740017460(17)191009(10)44K82118, 44K82618 (15NOV2019) (01)00380740017460(17)191115(10)44K82618, 44K85119 (22JAN2020) (01)00380740017460(17)200122(10)44K85119; b. List Number 8K2803 - Lot Number (Expiration Date) UDI: 44K79418 (23Jul2019) (01)00380740145255(17)190723(10)44K79418, 44K81018 (5Sep2019) (01)00380740145255(17)190905(10)44K81018, 44K82018 (9Oct2019) (01)00380740145255(17)191009(10)44K82018, 44K85219 (22Jan2020) (01)00380740145255(17)200122(10)44K85219; c. List Number 8K2809, Lot Number 44K84119, Expiration Date 17Dec2019, No UDI5,483 units
Z-2079-2019ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.; a. List Number 8K28 11 - Lot Number (Expiration Date) UDI: 44K78918 (18JUN2019) (01)00380740017477(17)190618(10)44K78918, 44K80918 (05SEP2019) (01)00380740017477(17)190905(10)44K80918, 44K82718 (15NOV2019) (01)00380740017477(17)191115(10)44K82718; b. List Number 8K28 12 - Lot Number (Expiration Date) UDI: 44K79518 (23Jul2019) (01)00380740145262(17)190723(10)44K79518, 44K81118 (5Sep2019) (01)00380740145262(17)190905(10)44K81118, 44K82818 (15Nov2019) (01)00380740145262(17)191115(10)44K82818, 44K84219 (17Dec2019) (01)00380740145262(17)191217(10)44K842196,623 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for the lot number on the calibrator label, which is listed in the recall for specific dates.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 48 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: May 24, 201912. FDA classified it Class III: Jul 25, 201923. Published in FDA’s Enforcement Report: Jul 31, 201934. FDA terminated the recall: Apr 1, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class III
  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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any safety risks?

The recall is for potential inaccurate test results, not immediate safety risks. The danger level is low risk.

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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-2078-2019 (May 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2078-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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