FastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode
Qualigen Inc is recalling the FastPack TSH Calibrator Kit due to an incorrect barcode linked to incorrect information. The barcode defect may allow successful system calibration, but TSH test results obtained could be higher than expected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall involving a labeling defect (incorrect barcode and information) in a diagnostic calibrator that may produce inaccurate TSH test results. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a score of 3 (High).
Plain-English summary
Qualigen Inc is recalling the FastPack TSH Calibrator Kit (REF: 25000024, UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: May 15, 2025). The recall affects 60 units of this calibrator kit used in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer.
The calibrator card contains an incorrect barcode linked to incorrect information. Although the FastPack IP System may perform calibration successfully using the affected kit, the TSH test results obtained could be higher than expected. This discrepancy between displayed results and actual values poses a risk of diagnostic error.
The affected lot was distributed to healthcare facilities and laboratories in 25 U.S. states: Texas, Mississippi, New York, Ohio, Montana, Washington, Pennsylvania, Minnesota, South Carolina, Georgia, North Carolina, Nevada, Wyoming, Alaska, South Dakota, Kansas, Nebraska, Vermont, Alabama, Massachusetts, Oklahoma, Utah, Wisconsin, Iowa, and West Virginia. Additional distribution occurred in Germany and Switzerland.
Laboratories and healthcare facilities that received this product should contact Qualigen Inc for a replacement calibrator kit. Patient results obtained using the affected lot should be reviewed and rerun if necessary to confirm accuracy.
The recalled product
- Product
- FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
- Manufacturer
- Qualigen Inc
- Affected units
- 60
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 (3)
- UDI-DI: 00816467020099
- Lot: 2405017-1
- Expiration: 2025-05-15
Distribution
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