The Recall Desk
ModerateFDA (Devices)·Z-2078-2019·Announced 2019-07-31

Abbott Recalls ARCHITECT BNP Calibrators Due to Stability Drift

Abbott Laboratories is recalling 5,483 units of ARCHITECT BNP Calibrators worldwide due to a time-dependent stability drift that affects patient and control test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard involves a stability drift affecting test accuracy rather than a direct physical injury or contamination, fitting the criteria for a moderate severity score.

Plain-English summary

Abbott Laboratories is recalling 5,483 units of ARCHITECT BNP Calibrators. These products are used for the calibration of the ARCHITECT iSystem when performing quantitative determinations of human B-type natriuretic peptide (BNP) in human EDTA plasma.

The recall was initiated because of the presence of a time-dependent stability drift in patient and control results returned from ARCHITECT BNP testing. This defect may compromise the accuracy of the diagnostic results generated by the calibrated system.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international locations. The recall covers specific lot numbers and expiration dates ranging from July 2019 to January 2020. Users should stop using the affected calibrators and contact Abbott Laboratories for further instructions.

The recalled product

Product
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.
Manufacturer
Abbott Laboratories
Category
Medical Device — Laboratory Reagent
Hazard
Affected units
5,483

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 (11)

  • 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
  • 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

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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