The Recall Desk
HighFDA (Devices)·Z-1819-2024·Announced 2024-05-22

VITROS Free T3 Calibrators recalled due to positive bias in thyroid test results

QUIDELORTHO is recalling VITROS Free T3 Calibrators used in thyroid testing because they may produce elevated results that could lead to incorrect patient diagnosis or delayed care.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of a diagnostic medical device with no reported illnesses or injuries, but the product poses a risk of harm through incorrect test results that could affect patient management. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).

Plain-English summary

QUIDELORTHO is recalling VITROS Free T3 Calibrators-IVD (Product Code: 111 2820) due to analytical bias that affects test accuracy. These in vitro diagnostic calibrators are used with Free T3 Reagent Packs to measure free triiodothyronine (FT3) levels in human serum and plasma samples.

The recalled calibrators may produce positively biased results, meaning test values read higher than the actual FT3 level. This positive bias can cause erroneous patient results or delays in testing that may impact patient management and clinical assessment of thyroid function.

Eight lot numbers are affected, with expiration dates from April 2024 through August 2024. The recalled product has been distributed worldwide, including throughout the United States and to countries such as Australia, Belgium, Brazil, Canada, France, Germany, Japan, and the United Kingdom.

The recalled product

Product
VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820
Manufacturer
QUIDELORTHO
Category
Medical Device — In Vitro Diagnostic
Hazard
  • analytical-bias
  • diagnostic-error

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 (8)

  • UDI-DI: 10758750008438 Lot Numbers: 3042 Expiry: 09-Apr-2024
  • 3052 Expiry: 02-May-2024
  • 3061 Expiry: 06-Jun-2024
  • 3080 Expiry: 02-May-2024
  • 3090 Expiry: 14-Jun-2024
  • 3100 Expiry: 29-Jul-2024
  • 3110 Expiry: 13-Aug-2024
  • 3126 Expiry: 04-Sep-2024

Distribution

Distributed nationwide across the United States.

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