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ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibratio...

FDA Device Recall #Z-2078-2019 — Class III — May 24, 2019

Recall Summary

Recall Number Z-2078-2019
Classification Class III — Low risk
Date Initiated May 24, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Laboratories
Location Abbott Park, IL
Product Type Devices
Quantity 5,483 units

Product Description

ARCHITECT 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.

Reason for Recall

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

Distribution Pattern

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.

Lot / Code Information

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 UDI

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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