The Recall Desk
ModerateFDA (Devices)·Z-3054-2020·Announced 2020-10-07

Medline Triage BNP Calibrator Recalled for Improper Refrigeration

Medline Industries is recalling 118 units of Triage BNP calibrators shipped with ice instead of dry ice, risking product degradation.

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 II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Medline Industries Inc is recalling 118 units of the Control, Calibrator Verified, Triage BNP, Model ALR88755. The recall was initiated because the product was shipped with refrigeration (ice) instead of the required frozen conditions (dry ice). This improper shipping method may have compromised the integrity of the calibrators.

The affected units were distributed in the United States to the following states: Arkansas, Arizona, Colorado, Florida, Maryland, Mississippi, Michigan, North Carolina, New Mexico, New York, Oklahoma, Pennsylvania, Rhode Island, and Texas. The recall covers specific lot and serial numbers, including 30718, 407522, 420694, 422646, 430000, 422647N, 422648N, 428255N, 428256N, 441421N, 441422N, and 441423N.

Healthcare facilities and consumers who possess these units should stop using them and contact Medline Industries for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Control, Calibrator Verified, Triage BNP, Model ALR88755
Affected units
118

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 (12)

  • Lot Number and/or Serial Number: 30718
  • 407522
  • 420694
  • 422646
  • 430000
  • 422647N
  • 422648N
  • 428255N
  • 428256N
  • 441421N
  • 441422N
  • 441423N

Distribution

Distributed in 14 states: