ARCHITECT BNP Controls recallZ-2079-2019 · Abbott Laboratories · initiated May 24, 2019

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

Abbott Laboratories notified customers on about 05/24/2019 via "Product Recall" letter. If customers did not have an alternate calibrator and/or control lots available in inventory and a valid calibration calibration curve has been generated, then customers should immediately order replacement calibrator and/or control lots. Valid calibration curves generated with the affected calibrator lots can still be used as long as controls not listed on the customer notification letter remain within range. The control lots listed in the letter CANNOT be used to validate the calibration curves. Destroy any inventory of the affected lots according to your laboratory procedures. If customers have alternate calibrator and/or control lots available in inventory, then discontinue use of the impacted lots immediately and switch to the alternate calibrator and/or control lots. Destroy any remaining inventory of the calibrator and/or control lots according to your laboratory practices. For customers who have, and are currently using, specified lots (outlined in the customer letter), expiration dates should be adjusted as instructed. Reference customer letter. The ARCHITECT software will continue to track to original dating as assigned during the manufacture of these lots. Manual tracking of the newly assigned expiration dates will have to be performed for each individual instrument, kit, and laboratory. Obtain replacement calibrator and/or controls prior to adjusted expiration to maintain testing. All future calibrator and control lots will have shortened expiration dating and will require adjustments to laboratory inventory and order management practices. Please contact your local Abbott representative for assistance and advice on optimization of workflow in your laboratory. Customers were also instructed to complete and return the Customer Reply form, notify customers if the affected products were further distributed, and retain a copy of the letter for lab

Recall details

Recall number

Z-2079-2019

Status

Terminated

Initiated by the company

May 24, 2019

Recalling firm

Abbott Laboratories

Quantity

6,623 units

Product code

JJX

FDA submissions

K060964

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.

Product description

ARCHITECT 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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• ARCHITECT 08K2812

  Abbott GmbH · Single (specified) analyte controls (assayed and unassayed)
  1 recall12 reports
• ARCHITECT 8K28-11

  Abbott Laboratories · CALIBRATOR, SECONDARY
  1 recall2 reports

Product lines

• ARCHITECTAbbott GmbH · 48 models · 526 reports · 8 recalls
• ARCHITECTAbbott Laboratories · 51 models · 5,426 reports · 11 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 83053).

• Z-2078-2019 · Terminated
  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…