The Recall Desk
LowFDA (Devices)·Z-2079-2019·Announced 2019-07-31

Abbott Recalls ARCHITECT BNP Controls Due to Stability Drift

Abbott Laboratories is recalling ARCHITECT BNP Controls because of a time-dependent stability drift that affects test results.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a stability drift affecting test precision rather than a direct physical hazard or reported injury.

Plain-English summary

Abbott Laboratories is recalling 6,623 units of ARCHITECT BNP Controls. These controls are used to estimate test precision and detect systematic analytical deviations for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT iSystem.

The recall is being conducted due to the presence of a time-dependent stability drift in patient and control results returned from ARCHITECT BNP testing. This drift may affect the reliability of the test results.

The affected products were distributed nationwide in the United States and worldwide to numerous countries. Specific lot numbers and expiration dates are listed in the recall documentation. Users of these products should contact Abbott Laboratories for further instructions on how to proceed.

The recalled product

Product
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 h
Manufacturer
Abbott Laboratories
Category
Medical Device — Laboratory Test Controls
Hazard
Affected units
6,623

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 44K80918 (05SEP2019) (01)00380740017477(17)190905(10)44K80918
  • 44K82718 (15NOV2019) (01)00380740017477(17)191115(10)44K82718
  • 44K81118 (5Sep2019) (01)00380740145262(17)190905(10)44K81118
  • 44K82818 (15Nov2019) (01)00380740145262(17)191115(10)44K82818
  • 44K84219 (17Dec2019) (01)00380740145262(17)191217(10)44K84219

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Abbott Laboratories under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · stability drift

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