ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP recall
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical…
Why was ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP recalled?
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)44K84219
- Product
- ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical…
- Recalling firm
- Abbott Laboratories
- Quantity
- 6,623 units
- 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 date
- July 31, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)